Computer generated transcript

Warning!
The following transcript was generated automatically from the content and has not been checked or corrected manually.

Hello. Hi, everyone. Um, good evening or good morning or good afternoon to wherever you are. Um My name is Jan. I am one of the UK Anesthetic representatives of Gas Global Anesthesia Surgery Obstetric Collaboration of which probably is how you heard about this event. So, uh just a round of introductions for those who might be new. So every two months, um we have an event um that rotates in specialty. Um That is our Journal club. Um We started a little bit late this year because there were a lot of different events happening around the world. Um So uh we start with anesthetics. I think the next one surgery, every two months we'll rotate and then there's ob obstetrics. So every six months you'll see an anesthetic theme, surgery, obstetric, et cetera, et cetera. Um, in the audience, we have quite esteemed audience. Um and I really love, um, and thank them for being here. Um, and I, uh you would have known that we've got two papers that we'll be discussing quite seminal papers actually. Um and uh we'll be discussing them with people who have been involved with them. Um So without further ado I'm just gonna pass on the stage to Alex but before that I must er give her a round of introduction. So doctor Alexandra, er to she is an, an anesthesiologist in Durban in South Africa. She is also an honorary lecturer in UK ZN University of Kwazulu, Natal in er South Africa. So you guys have had the privilege to hear uh fresh off the oven, I suppose uh about Asos Pizz. Um So Alex is the P I. So the principal investigator of Aos Pizz. Um So for the paper that you guys have got is the uh P impress of the outcomes after surgery for Children in Africa, a 14 day prospective obser observational cohort study. Um So without further ado, I'll pass you on the stage, Alex. Welcome. Thank you very much and thank you for inviting me to speak this evening. So I'm going to be talking about S SPS um which was a 14 day prospective observational cohort study looking at outcomes after surgery for Children in Africa and um presenting on behalf of the S SPS investigators. And I would just like to say um that it's a privilege to be a part of this group. We have an amazing group of researchers across the continent and it's been an incredible collaboration. So, just a declaration we received um funding from the South African Society of Anesthesiologists and the Association of Anesthesiologists of Uganda. And this money was used to pay for ethics fees and some of the funding from the South African Society went towards um administration of the study and data management. Yeah. So I think um everybody in this audience knows that access to safe and affordable surgery is a public health priority. And if you look at Africa, 40% of the population are Children. Um and this is compared to 25% which is the global average. So this is a significant proportion of our population. Um and a lot of these Children are going to need surgery. We all know from the adult data that outcomes in adults are poor. And we found in Assos that the mortality in adults was twice that of the global average. With regards to pediatrics, there are some data um from Africa. We ran a study in South Africa um where we found the mortality was 1.1%. Um There was a study in Kenya with the mortality was 1.7% postop. So these studies came out of middle-income countries. There are other studies from single centers across the continent. Um However, prior to a PS, the data that we had wasn't generalized to the population of the entire continent. So we decided to do S SPS. Our objectives were to determine the incidence and predictors of inhospital POSTOP complications and perioperative mortality. So, our primary outcome was in hospital POSTOP complications up to 30 days, POSTOP and our secondary outcome was in hospital mortality up to 30 days postop. Um We also looked at intraoperative critical incidents and that's going to be the next paper um that we're working on now. So that will be discussed in a separate paper. So this was a 14 day prospective observational study of Children under the age of 18, undergoing surgery in Africa. We included hospital level data and we tried to look at as many hospitals as possible across all levels of care. Um We recruited from January 2022 until December 2022. In total, we recruited 8625 patients from 249 hospitals in 31 countries. Originally, there were 43 countries that requested participation. Unfortunately, 12 of them could not obtain ethics approval. So we ended up with 31 countries. Um and 266 centers, there were 17 centers that had no patient recruitment during the 14 day um recruitment period. So we ended up with 249 centers that recruited. Um well, they found 8808 eligible patients. 100 and 32 were not recruited. 26 were excluded because they were 18 years or older and 25 were excluded as um those patients did not provide consent. Um Just of not, we had very little missing data. So for the main outcomes for mortality, um naught 0.3% missing data for complications. 1.3% missing data. And for all variables, there wasn't more than 1.4% missing data. So we had really good complete data in terms of the hospital recruitment, the majority of patients um were at third level hospitals. Um and this was where also the majority of hospitals. So we used the DCP three grading of hospital levels of care. So your first level hospitals would be rural or district hospitals um which have 50 to 200 beds. Your second level hospitals would be those that have 250 to 800 beds. Usually um some specialist care offered. Um and then the third level hospitals would be your academic um university National um high-level hospitals that have um a much larger number of beds. I think it's 800 to 1000 500 beds. In terms of the hospital data, um operating rooms were considered safe for anesthesia and surgery in neonates. And 54% of the hospitals in infants and 66% of the hospitals in Children, 1 to 6 years of age and 84% of the hospitals and in Children, older than six and 91% of the hospitals, there was an unreliable electricity supply in 48 hospitals and unreliable oxygen supply. In 42 hospitals functioning incubators in 100 and 73. And then a pediatric emergency airway trolley was present in the operating room in 100 and 24 hospitals, a hospital protocol for pediatric pre op fasting was present in 100 and 45 and a protocol for pediatric emergency airway management. In 96 hospitals in terms of the patient characteristics, the mean age was 6.1. The majority of patients were male. A SA one having elective surgery. And um after hours operations took place in 17.8% of patients. So as I mentioned before, the majority were a sa one with only 1.6% of patients being a SA four or five. The most common comorbidity was a neurological disorder followed by cardiac disease, followed by a current respiratory tract infection. In terms of the primary indication for surgery, the most common primary indication for surgery was congenital. Um and this was followed by noncommunicable and then traumatic and infective were quite similar. The most common type of surgery was gastrointestinal, followed by kidney urology, followed by orthopedic and after that uh ear, nose and throat surgery. So our primary outcome was complications. 18% of Children developed postoperative complications and the most common group of complications were infective. The most common complications were a surgical site infection and bleeding in the POSTOP period. The factors independently associated with POSTOP complications were the neonatal age group and increasing as a a chronic respiratory disease, neurological disorder, cancer occur respiratory tract infection, other comorbidities, emergency surgery, major and intermediate surgery, infection and trauma. As the primary indications for surgery, bone surgery and an increasing duration of surgery. Uh, secondary outcome was mortality and the mortality was 2.3% when you noted that um the majority of patients who died were having gastrointestinal surgery. And um we did a POSTOP analysis of this and found that most of these patients were in the neonatal and infant age groups. So, the factors independently associated with POSTOP mortality were the neonatal and infant age group and increased um increasing a sa score cardiac disease, neurological disorder, current respiratory tract infection, other comorbidities, having emergency surgery, having burn surgery and an increasing duration of surgery. So, complications occurred in 18% of patients. Um 100 and 99 patients died, the of the patients that died, 11.6% died on the day of surgery and of the patients who had complications, 10.8% of them died. We decided to do a meta analysis and um basically, we did this to provide a context for the results of the study. Um And basically, we were just looking at per op mortality for Children following surgery. So the question was, what is the report of global peri mortality rate in pediatric surgery? Um Peri mortality was defined as death occurring within 30 days following a surgical procedure. Um We yeah, searched standard databases. Um This was done in July 22. So kind of halfway when we were halfway through recruitment and we basically tried to look for studies that were similar to PS. Um and that were reporting similar mortalities, we um excluded studies that reported on single surgical procedures or studies that reported on um age group such as just exclusively the neonatal age group. Um We looked for studies that were published um in the previous 10 years um in the pediatric population that had more than 200 patients. Um And I think I've mentioned most of the excursions. So we ended up with nine studies and then they added SPS to that. So there were 10 studies in total with OS PS. Um what we found overall that was that the period of mortality per 1000 patients was 6.88 and in Africa, 17.91 compared to Europe and North America, uh weight was 2.18. So essentially what we found with the meta analysis that there were eight times more deaths occurring in Africa um than in Europe and North America. So the mea um sorry to conclude about SPS. This was a prospective observational study of surgical outcomes for Children undergoing surgery. In 31 African countries. The principal findings were POSTOP complications occurred in 18% of Children and hospital mortality rate was 2.3%. The main risk factors for POSTOP complications um were coexisting disease, intermediate and major surgery, emergency surgery and neonatal in infants were independently associated with POSTOP complications and mortality factors contributing to the difficulty in providing safe anesthesia and surgery include unreliable oxygen and electricity supplies and a lack of protocols and procedures to support safe clinical surgical practice. So, the poor outcomes following surgery for Children in Africa are an even more serious public health problem than what we found in adults. Um There's an urgent need to improve safety and effectiveness of anesthesia and surgery for Children in the African hospitals. Thank you. Thank you. It's been absolutely amazing. Um Just uh thank you so much, a lot of um very enlightening thoughts. Um As we go along, I just wanted to introduce the concept of the chat box to people if they are too shy to ask questions. Um And uh but I, and also introduce a few people in the audience that I can see um that will be useful. Um So I can see, I'll probably just go around um the, the Gas O team first and then um and then I'll go straight to the questions just so to give some time for people to gather their questions together. So, Gas O is a global and see the surgery obstetric collaboration. I realized I didn't do the um promotion bit. I think I'll get uh slapped on the hand if I don't say anything. Um We innovate, we uh um advocate and we collaborate with uh international collaborations um in the audience. We have a few of our committee members including Lambert. Uh We also have our international anesthetic rep Maria. Um, and hi Mary, and we've got, um, Ryan who is our president who's also here, RNA, who is one of our coms uh representative who is also here and obviously there is Jews, um Julia Harrington, who is also a new uh UK anesthetic representative who's also in the audience. And a lot of you probably know prof beard is also in the audience. Um, he started, uh I think he's one of the chief coordinators and investigators for the first AOS and he was here around last year this time in the Gas Surgical Journal Club talking about uh AOS two. So let me have a look, if there are anything in the chat box, there seem to be some great. Oh, so, so uh Clare asked really interesting study and large sample size. Um How did you go about recruiting on such a large scale for this study? So that's our first question. So the question is about how did you go about recruiting on such a larger scale? Um I think we're really, really fortunate in that. Um Bruce came before us and did the adult study. So Bruce um had already established a really large network across the continent. Um And um we have a for the African Perioperative Research Group. Um So I think we're quite well organized from that point of view and then basically um used people in our network to find and recruit um investigators from around the continent. Um And in fact, I managed to link up II found somebody via Facebook as well. So, um yeah, and yeah, we've just ended up with a really huge network of people that believe in the work that we're doing. Um And that's how we ended up with such a large recruitment. That's really cool. Um uh Yeah, I heard I was recently at the World Congress of anesthesiologists and I heard about a lot of my colleagues in different countries um collaborating for this work. Um My friends from Cameroon, my friends from uh uh from Senegal, they all all all talked about contributing to this piece of work. Um VNA, VNA, our commons rep said, er thank you doctor to er insightful and essential piece of work. Was there any data collected about why there was a requirement for surgery ie congenital or acquired conditions and any impact on outcomes depending on congenital versus acquired? Um So it uh the study um was a very pragmatic study. So we don't have too much granular data. Um We did obviously look at the primary indication for surgery. So, yeah, what we found was that um the majority of patients were coming for a congenital indication and that um infection and trauma were so coming for if the primary indication was infection or trauma. Um that was a risk factor for developing a complication. POSTOP, I don't know if that answers the question. That. Absolutely do. Um So Julia, this is like a great, wonderful Julia asked, did you do any subgroup analysis uh of outcomes in centers which did have pediatric or neonatal er contingency plans and anesthetic provisions in place? I suppose that will be your level three places. Um er versus those didn't, I suppose those would be, I think what she was uh trying to allude to maybe the super pediatric hospitals versus the, the hospitals that majority do adults and have a few pediatrics. Did you do any subgroup analysis on those? Julia? Feel free to tell me if I've interpreted it wrong. Um So I think she's talking about what other outcomes differences. Um That yeah. Um Bruce can correct me if I'm wrong. We did look at hospital level and um there was, I might need Bruce's help. There was no difference between, within um between hospital levels. Ok, cool Bruce. Did you want to add anything? Um Hi. Hi Jan. Um Thanks. I'll just have to check that quickly. Um If you give me, give me a sec while you go on to the next question, I'll check it. Uh I understood um Julia's slightly differently. I understood it as um asking could we see a difference between hospitals that had maybe a more in, had more infrastructure or preparation for pediatric surgery than those that did. Uh in other words, hospitals that have protocols versus hospitals that didn't we have not looked at that but that's a very interesting question and we could look at that in the future, but in the interim, I'll see, I'll just go back to the data quickly and have a quick look about the questions about the different levels while Alex carries on. Sorry, it might be just me throwing a Spanner in the woods. I'm so sorry. Um Cool. Thank you Bruce for engaging in that. Um, I, so, well, my question would be because I am a budding pediatric anesthetic enthusiast, I suppose. Um, now working in a tertiary pediatric center, um I would just wanted to ask actually, um, were there any, so you talked about different complications? Were there any um, subgroup analysis in terms of the airway complications? Because um from the nectarine and the apricot studies, they tend tend to allude to the smaller the younger, which is similar to what you found in the almost composite uh complications. Um But did you find any, what was airway looked into closer in terms of the neonates and uh a a 123 people in terms of uh airway complications? So that's gonna be the next paper looking at intraoperative critical incidents. So, um, airway complications will be in that. Um We, yeah, so we haven't looked at it yet. So all of these complications that we are talking about are POSTOP complications. So things like surgical site infection, bleeding. So things that happen in the ward afterwards. Mhm. That's wonderful. That's great. Um Let me have a look actually, do you wanna tell us a bit more about what's happening next? Because that could be what we piggyback on um next time and see how it's going. So what's the framework, what you guys are thinking about? Um what to do? Um Because we understand AOS adults, if I'm allowed to call, they started with data like this and then they went into looking into what was happening in terms of where the, um where the qualitative um component of it came along. Um, it is quite striking. Um because when we say adult peroperative mortality in Africa is two times the mortality complications, uh mortality compared if I'm not quoting wrong. Uh Whereas in er, pediatrics is eight times, where do you after being a researcher and a pragmatic researcher in your head? And where do you see it as a low hanging fruit? What, what could be improved um to, to help us improve? I know it's a very big question. But um uh where do you think is the primary bits that we need to sort out first and then we can look at the others. Um So just first off, it's something that our group still needs to discuss, we haven't really started looking at what the next steps will be. Um And uh in my mind, probably looking at it for something with infection. Um Yeah, the problem is interventional studies can start getting, they can be very complex and it can be hard to do something. Um, pragmatic and simple what um has happened in South Africa after the initial South African study is um one of my colleagues is running an interventional study, um looking at anemia and just seeing if she's doing a pilot study at the moment, um if giving preoperative deworming and oral iron tablets um helps improve outcomes. Um And even that when she started, she thought it would be a very simple thing has, um, been quite tricky at times. I think Bruce has just put it on the chat. Oh, of course, the highest mortality and complications in the tertiary hospitals? Wonderful. Um Thank you so much. So, in that report, um we've got Eli Camba asking, um, did the study include both elective and uh emergency surgery? And if so were there any difference or was there only looking into elective or only looking into emergency surgery? Um, it was looking at both and um having emergency surgery was a risk factor? Yeah, as a lot of these are, so I'm gonna spend this around a little bit because uh one of the, the joys of having Journal club here is also having you guys here um to talk about the journey and also inspiring people to participate. So, um my question to you, uh there's no right or wrong answer um to both of you actually, Bruce and Alex. Um What has been the hardest bit um of uh coordinating and being P I of this? Was this, was it the getting people or was it the recruiting or was it doing ethics or was it the language or was it getting buy in or was it getting data? You seem to have a really good data, solid data capture rate. So which bit was the hardest bit um for you? And if I'm allowed to entertain my very humanity itself, um what kept you going basically? So what was the hardest bit and what kept you going? Um So 1st, 1st of all, I think we're just really fortunate in that um everybody that's involved uh is very keen um and really believes in the work. Um I think probably the hardest bit um was in a lot of countries trying to get ethics approval. Um Yeah, that's probably the biggest hurdle. And um one of the big issues is that um it costs a lot of money to get ethics approvals. Um And we didn't have a huge amount of funding. So we had to kind of limit um how much we spent on that. Um Bre was amazing and persuading a lot of ethics committees that this was such an important study that they didn't need to charge us. Um So that was quite helpful, but definitely the ethics was a problem. And as you can see, we, we had quite a few countries that we had really keen people and they were just like we never get ethics in time. Um Yeah. Um And what kept you going? Uh I think this is just from the beginning being a passion project for me. So yeah, it's amazing and everyone needs one of those passion projects are going. How about Bruce? What's your, what's your um I know if you've got your new book but what has been your um what has been your crux point and what's been the hardest bit? And how do you get going and seeing that you have such great persuasion power in ethics, any works of wisdom, how to learn such great nudging powers? Um I think uh similar to, I think Alex summed it up really well, you know, as a, we are a community who believe in what we're doing. Um And we, we honestly are passionate about trying to improve outcomes in Africa. So, you know, as a collaborative group, I think we work really well together. Uh I think our biggest struggles are um systems which aren't well established and, and, and ethics is very difficult, but, you know, it's um it's very powerful just to speak to people. And so, you know, ethics committees um are doing their jobs, but there's no ways we can pay big fees to 100s of ethics committees and when you just take the time to meet them and speak to them and explain the importance and the power of doing this as a big collaborative um nine times out of 10, they come on board immediately, they can see the importance. And so I think it's really just this is about communication. Thank you for the great words of wisdom. Um Let me just see if the chats have any more questions. Um Hi, everybody. I'm Julie asking all the awkward questions. Um Can I ask you another question? I think this is amazing data that you've collected for us and um is pretty groundbreaking. I think in terms of outcome data in this population, um I was, I worked in a tertiary center um in Africa and I was interested as to how you followed up these patients because um it's sometimes very difficult to trace patients perioperatively in the, even in the in the hospital setting. And I was wondering how, how your data collectors did that? Was it a kind of very laborious task? Um notoriously or, or, or kind of your data is phenomenal? And I was just wondering whether there's any tips in terms of tracking patients through the perioperative setting that we could take. Um if we did want to do cross sectional analyses in these places, I think, I mean, I think one of the key things is our POSTOP um CRF was one page. The Interop CRF was one page. There were very few data points to collect. Um That's a key thing because I think you can get investigative fatigue. Um And I think the more data points you have, the more likely you're gonna have um missing data or incorrect data. Um Yeah, keep it simple. Yeah. Anything uh for sure. I think, keep it simple. Uh II think also the benefit we've had is we've grown a community over a few projects now. And so the community has become more and more familiar with um what is needed. And so if you look at all our um studies each time the uh data completeness improves and II feel very proud of the work we do because I think the data completeness is, is impressive. But like Alex says, you know, we don't have any nice to haves every data point is there for a reason and we ask one question and that's all we try and do. So it's very simple. And I think the important point is we, we actually don't have data collectors. These are all clinician investigators, so they're working in the hospital. So they go above and beyond to do this work. So we try and expect uh their time and also we recognize everyone. So it's a, it's a group authorship. We don't mind if our hospital has 50 people. Some hospitals have loads and some have a view, but whatever is needed to make it work in a center, we would accept jules. Are you happy with that? Yeah. Any further questions? Sorry. Yeah, that's, that's great. That's um very good practical advice. And um yeah, lots of people here I think have, have worked in these settings. So, yeah, thank you. That's amazing. Um I'm just going to give a few minutes for the chat box to see if there are any more questions. Um And then we'll see where we go from there. But um and I also let you know um just while we're talking about it, um they're currently collecting data on pediatric surgical outcomes in Latin America. So um that's gonna be something to look forward to s and what's your prediction about the results of those? I don't know, I don't know enough about Latin America to make a prediction. You'll have to ask me about that. That's great. Wonderful. You can stay tuned. I don't know much about Latin America. I don't II I genuinely, I'm excited about all this. It's amazing. Let me see. Um J Yes. Um in Latin America they've actually just uh completed the adult study. Oh And um uh I think they have completed the analysis as well. So you're gonna see that soon. So that will also be very interesting. And the data is directly comparable. I think that's the strength, you know, big, big groups uh using the similar protocols or the same protocol, more or less allows one to get a much better feel for what's happening in different regions and what's what's driving morbidity and mortality. That's amazing. Will we therefore be complete in the world's data. Majority? No, no, not by long shops. Um Are you going to Antarctica? Something else we were talking about Antarctica because maybe we just, we have 100% complete data for that one patient. That would be amazing. That would be a perfect track record. That would be a good reason to go to Rotherham and whatnot. But you know, in all seriousness areas which are missing, which I think are important, Asiana, you know, that whole section is really important and hopefully in time, um people can get to document what's happening. That'd be amazing. So for those who feel free to correct me Bruce, for those who don't know that it's a whole batch of um preoperative uh prospective studies. So there's the ASOS that I would say the original, then, then there's ASOS two, then there was Asos quick care and then there are two more and I think there's one per and then there's per uh Asos peat. Have I missed something I must have, I can give you like a very quick history. So the, the first study was E OS the European Surgical Outcome study. Um And that, that really was a landmark study. And Rupert is um set a very good methodology I think for doing things PMA and that was just looking at mortality. And then from that, um uh Rupert went on to develop ISO, which is the International Surgical Outcome study. And we basically um replicated that in Africa's Asos and now uh So that's mortality and complications. And now the Latin America have just completed that and then the has of speed was um Alex's um work. Uh So Alex developed uh a pilot first um in South Africa to, to test it using the whole concept of uh S OS and it was very successful and the learning from that uh was some small changes uh to the protocol and that became as of speed. So that's the first really big um pragmatic surgical outcome study in pediatrics. And now Latin America is recruiting at the moment. That's absolutely amazing. Um I think we're more or less uh No more questions asking. I feel like just people being shy, that's all. Um But I um I think I won't disturb you guys anymore because um I know it's late in South Africa, but I just genuinely have a great heartfelt. Thank you for both of you, for your amazing work and your great support. Um I can't thank you enough. Um And I'd love to, I can't wait to see this paper and the Latin America paper and the future papers. Um But thank you so much for your continued support for gas and doing this all in your own time. But uh thank you so much, feel free to stay behind. But I know there is something called a bed and a sleep time. So um if you want to excuse yourself and depart, there are no hard feelings. Don't worry. Um But that's absolutely amazing. I think I'm gonna give you a, a good round of applause and thank you so much for doing this. Thank you very much. Thanks for helping me. Thank you for having us. Thank you. Thank you. Thank you. Take care. Thank you, cheers. So without further ado, let me get our next speaker on stage, which I think he is already on. Um Can you turn your mic on if you're on already? Mac. So our next speaker is Doctor Malga. He is a final year um uh anesthetic trainee in Zambia and he's currently the chief registrar in er, university Teaching Hospital Lusaka. Um, he will be talking to us. Oh, sorry, let me just get my thank back. He'll be talking to us about uh a study that um, actually also recruited in his hospital. So we went from annex's side of them being P I. Now we're going from um, er, er Maxide where he, er, was one of the recruiting hospitals for one of these studies. Um, so it's a different side but II feel the audience of uh gas up would actually be interested in hearing both ends of the story. So we'll be talking about the paper effects uh of an early resuscitation protocol in, in hospital mortality among adults with sepsis and hypotension. So this has all uh um all been sent to you guys beforehand. If you haven't, I'll get the PDF into a chat box. Um but without further ado I'm gonna um give you a very good doctor Mac Kalen who has spared his time for his suddenly er on call period to come and actually speak to us. Um So welcome Mac, thanks for doing this for us. This is absolutely amazing. Thank you. Hi J. Can you hear me? Well, I can hear you. Well, awesome. Let me know if that changes uh network connectivity over here can be a little bit unpredictable. Um So I'm just going to try and get my slides up. Could you let me know if you can see them clearly? Yeah, you can see them well. Yes, we can see them. Ok. All right. Thank you so much. Um So I am I going to be speaking about a study that was done at the university teaching Hospital where I currently am right now. Um And uh I've got nothing to declare about the study. I was not directly involved um in it. Um, but it was a study that was, uh, like I said, done here. Um So thank you so much to gas for giving me the opportunity to uh speak about, about um this interesting paper. And um the reason that um, I guess I find it so interesting is because uh mortality from sepsis, um really around the world remains pretty high but in low and middle income countries is particularly high. The has this um over one in five patients around the world dying from sepsis. Um We know that current usual care in U TH and in many other uh hospitals such as ours, the use of an early resuscitation uh protocol isn't really done and um patients are generally kept a little bit more dry. Um We are also aware of the infamous or famous Rivers trial. However, you want to look at it um that was done in a more high income setting that suggested early goal directed um therapy in sepsis may decrease mortality. And this trial really influenced many things including um the surviving sepsis campaign guidelines to recommend um these boluses of, of fluid. However, the benefit of this kind of approach um has generally remained unclear in uh settings such as mine. So the objective of the study was to determine whether a se a sepsis protocol with early resource of um intravenous fluids and early administration of vasopressors and blood transfusion would help in decreasing this um in hospital mortality compared with the usual care of keeping patients dry. Uh in this African um population who had sepsis and hypertension. So, the historical context um when it comes to other studies, um other than the River River trial that I spoke about is that they prior to the study, there were three other studies that had looked at something similar uh and had found some level of confliction in results. There was a before and after study done in Uganda that suggested decreased mortality when they gave um uh different interventions including uh IV fluid boluses in patients with sepsis. Um However, a randomized control control trial was done in Zambia um at U th itself um where they tried um an early uh intravenous fluid bolus um protocol and they actually had to stop the study early because um they found that there was uh increased mortalities in the subgroup of patients who had presented to the hospital with hypoxemia and tachypnea. And so this study was stopped early. Um There was also a separate randomized controlled trial which uh was done in Kenya, Uganda and Tanzania where they looked at um fluid boluses in Children with uh severe febrile illnesses. And in this study, they also saw an increased mortality with these intravenous fluid boluses. So, of course, um really interesting data from all of them, but uh none of them really had um um uh specific markers of tissue hypoperfusion. Um So, the specific aims of this particular study were to assess the impact on. Uh and these are from what they put in their protocol, which is available. Um The first two, they actually did look at the last two were not, ultimately um looked at in the paper that was published, although they did remain in the protocol that's available online. Uh And so the two that we'll be looking at here, the assessment of the impact on survival of a simple evidence based protocol for severe sepsis or septic shock. And um the other one was evaluating uh the cost of implementation of a severe sepsis protocol. Um They didn't look at um at uh the performance of um gene expert uh and uh urine lam for diagnosing TB in HIV, positive patients with, with sepsis. So, like I said, you could find this journal online and I think it's gone out already. Um The funding was listed as coming from Fogarty International Center of the National Institutes of Health. Uh It was a prospective randomized controlled trial that compared I go direct um uh therapy to usual care for patients with suspected sepsis and hypotension. The population was essentially all the patients that were presenting to U th emergency department um between 8 a.m. on Mondays and 12 p.m. on Fridays. And um all the patients had to be over the age of 18. So it was adult patients only and the intervention that they did was they had essentially two groups. One got the sepsis protocol, one, they allowed to get their usual care that the hospital provides. Um So the outcomes that they looked for, uh the primary outcome was in hospital mortality. Um So looking at the difference in mortality between the sepsis protocol uh group versus uh mortality in the usual care group. Uh while the secondary um outcomes that they looked at was 28 day mortality and time to death. Uh they also looked, they also had interest in seeing whether um, hypoxia worsened or tachypnea, um, worsened uh in these patients. Um Other things that they looked at was the amount of fluids that were being given to these patients. Um, antibiotics. The time from presentation to administration of the antibiotics, uh where the blood transfusions were given the amount of vasopressors as well that were used for the patients, um or who got uh vasopressor rather. Um other things that they tried to look out for were adverse events such as dopamine extravasation. Um and iatrogenic pul pulmonary edema as well as reactions to the blood transfusion. So, like I said, they looked at all the patients uh presenting to the e um eligibility for the uh paper. I mean for the study was that one, you had to upset sepsis. They diagnosed this based on sir criteria. Um And uh two, you had to have hypotension as well, which they defined as a systolic under 90 or uh mean arterial pressure, less than 65. They excluded patients who did have already present with hypoxemia and severe tachypnea. And um the reason for this was obvious in that there was a previous study done in the same setting where they gave boluses and that study got stopped because this particular group of patients had um a higher mortality. So they did not include um uh these patients in the study. Um They also excluded patients with gi bleeding patients with established heart failure. Um endstage renal disease, obviously, because fluid administration of those patients would be different, would be different from regular patients, patients who already had uh elevated uh JVP S or suspicion of um a high CBP to start with uh or patients who needed immediate surgery. Um So enrollment into the study basically occurred within four hours of um Provigil uh when it came to randomization and blinding. Um they used a computer randomization and uh allocation was basically uh through sealed opaque envelopes. Now the envelopes opened up the informed consent. The patients, clinicians and uh clinical study personnel were all aware of the assignment. The only people that were not aware were the people analyzing. Um excuse me, sorry. Um The people that um we, the, the people that were um unaware of, of the assignment where um the study personnel that were responsible for um assessing the outcomes and data analysis, um treating clinicians uh chose the location of care where the patient would go, they go to the ward or they go to the ICU and they also decided on um antibiotic selection. Um And this also included the use of um empirical treatment for TB uh as well as malaria treatment. They also had a dedicated study nurse who measured vitals for the patient. Um The nurse also supervised all the um ordered uh fluids and medications. Now, 3501 patients were essentially assessed for eligibility and uh they excluded right from the uh lot of them, um or nearly 2000 just didn't have sepsis. Uh Another 1000, 200 did not have hypertension and 100 and 16 had incomplete screening. Um, 382 met the criteria and um of those they excluded a further 100 and 70 for various reasons including um finding that the patient had heart failure or had hypoxemia or something like that. Um Eventually they ended up with 212 that were randomized. Um And uh 100 and seven went to the sepsis Protocol group while 100 and five had uh got usual care. Um around uh a total of around 15 were lost to follow up. So, baseline characteristics of the patients average age was around um was between 35 to about 37. Um around the majority were male, but just slightly over 50%. Um But an interesting statistic was that the majority of the patients in both the sepsis protocol and the usual care group had HIV. So nearly 90% of the patients in this study had had um had HIV and uh most of them were on um antiretroviral therapy uh for around um around 50 days. Um Other uh things to look for was that um the other thing that they took note of was the SA PS uh three score that the patients presented with, which were pretty similar um in, in both groups. Um They also collected baseline labs um with an average HB of the patients being around seven. Um So when it came to the sepsis Protocol group, um these patients received a 2 L bolus of fluid of isotonic crystalloid. Now, they didn't say what crystal light exactly they gave, whether they preferred to use saline or ringers. Um but they gave 2 L within an hour and an additional 2 L over the subsequent four hours and after each liter was administered, they would uh basically reassess the patient's vitals. Uh They also looked for raising JVP um and uh looked for increases in respiratory rate as well as hypoxemia. Um The they limited the fluids to around 4 L um of fluid and this included any fluid that could have been given to the patient prior to um enrollment in the study. Um If the patient's map remained less than 65 after those boluses, they would then start um a dopamine infusion at around 10 MS per kilo. Um It was also recommended in the protocol to give uh blood transfusions to patients less than seven with, with an hp of less than seven in the usual care group. Um Basically in this group, the, the treating clinicians are the ones who decided how much fluids to give the the patient and when to use vasopressors and to give blood transfusion. But generally, it was seen that these patients received. Uh um most of these patients did not get a bolus of fluids and um a very small amount of these patients received vasopressors and also a small amount of these patients will get a blood transfusion. Um So when it came to data collection, uh most of these patients were not ambulatory. So they used uh upper arm circumference um to assess nutritional status. Um The study person also looked at all the fluids that were being given up and they also followed up um up to 28 days to see uh outcomes for these patients up to that point. Um For study power, they used a previous study that was done in this setting. Um And uh they calculated that enrolling 212 patients would provide a power of at least 80% a level of 0.5 0.05 sorry um to get an absolute risk reduction of 20%. Um They also, when it came to analysis, they uh analyzed um with a modified intention to treat fashion. Um um uh for all, for the, for the, basically for the patient um groups that they were in. And um um they basically reported all their uh continuous variables as uh means and standard deviations as you will see shortly as well as the category called variables as frequencies and proportions as is the usual thing. Um They uh um differences between groups were analyzed using uh T tests for um parametric continuous variables. And um the chi square test for categorical variables and they also use the Mann Whitney test for nonparametric variables. Um So, the primary analysis, which was an essentially which group had more mortality. Um They analyzed that using the square test. Um And in the secondary analysis, they also um adjusted for the patient S ap scores as well as different um subgroups such as the G CS, the baseline HB, baseline lactate and all of these different things. And we will look at what results they got. Uh Ultimately, the analysis was done using Stata um which I'm sure we're often familiar with to some degree. Um So when it came to hemodynamic interventions, uh they found that in the six hours after presentation to the ED patients in the sepsis Protocol had received at least around 3.5 L of fluid. While in the usual care group, they had only received around 2 L. So um there was a statistical difference in how much uh statistically significant difference in how much fluids were being given in the two groups. Um So um a total of 41 patients in the Sepsis Protocol group received 4 L um or greater IV fluids in the ED. Um While um they also saw that uh the remaining 65 patients in the Sepsis Protocol Group um where uh um sorry, rather, in, in among the remaining 65 patients. Um 61% of those in the sepsis pro group group had to have um a discontinuation of fluids uh due to uh this predicted increase in um respiratory rate or a decrease in arterial um oxygen saturation. Um Only 50 per percent of patients in the usual care group received any uh fluid bowler. So less uh around um less than half of these patients basically got a fluid bowler. So very different from what was happening in the Sepsis Protocol group. Um What they saw was that BP generally increased over the first six hours. Um but around 14.2% of patients did require a dopamine infusion. They also saw a general decrease in lactic acids, um um concentration in um in, in both groups, but the the decrease was greater in the Sepsis Protocol group where they were giving more uh IV fluids. Um The majority of the an interesting thing that came out here was that the majority of these patients were managed on regular medical wards. Um because of uh limited uh space on the intensive care unit, only one patient made it to the ICU. Um So we we al they also saw that more patients in the sepsis Protocol um experienced a decrease in oxygen saturation or an increase in respiratory rate. Um Most common admitting diagnosis were pneumonia or suspected TB. Um And uh a percentage of these patients also had positive uh TB blood cultures. Um So, clinical outcomes um that they saw the primary clinical outcome that we spoke about, which was in hospital mortality. Was found to be higher in the sepsis protocol group, um um uh than in the usual care group. Uh So, and this was found to be statistically um uh significant. So we had a 48% mortality in the um sepsis protocol group and um 33% in the usual care group. Uh, 28 day mortality was also higher in the sepsis protocol group at around 67% versus 45% in the usual care group. And when they adjusted for their SAS three um scores, they um still found that mortality was greater in the sepsis protocol group than the usual care group. Um They also found in the time to event analysis that the probability of surviving if you're in the sepsis protocol group was much lower. Um Yeah. So um they also found that in all those uh subgroups that I spoke about the uh mortality was basically higher if you're in the in this sepsis protocol group where you are getting more IV fluids, hospital stay was also lower in the sepsis protocol group because these patients had a high higher mortality. Um uh but the rates of those adverse events that they're looking at like um um extravasation um of the dopamine infusions was pretty uh similar. So this graph just demonstrates um the probability of survival. And you can see in the orange, that's the sepsis protocol which was much lower as the days went on. Uh the chances of surviving if you're in the sepsis protocol group was a lot lower than uh the usual care group. And um I've, I've highlighted a lot of the results from this table already. So I'm not gonna spend a lot of time on it, but basically most of these subgroups mortality was higher in um the sepsis protocol group. So, what we can see was that this protocol for early resuscitation did increase mortality in in the patients with um over usual care that was provided. Um uh So the sepsis protocol gave more fluids, um used more vasopressors and had more lactic clearance, but still uh resulted in a much um more frequent worsening of hypoxemia to kidney and also higher rates of in hospital mortality as well as 28 day mortality. Um And this may have important clinical implications in our setting. Um So we, we know when we compare this to other trials, like I spoke about with the, with the Rivers trial that has influenced uh the surviving sepsis campaign guidelines. Um When we look at that rivers trial, it was just a single center trial. And um although they showed an improvement in mortality in, in the patients that got this early goal directed therapy, um uh This really wasn't what we saw uh in, in our, in our group of patients, there were some differences in the trial. So for example, in their setting, they did have uh central lines in place and they looked at CVP um in this trial particularly, they tried to use JVP instead because of resource limitation. They tried to use uh measuring the JVP, uh which um wasn't very effective. I would, I would say um we also know that three other multicenter trials found no difference between early go therapy and usual care in resource uh intense settings. Um We've seen the promise trial and other trials um uh like that. So the uh this study that we've just spoken about was the third RCT in this kind of setting to suggest that an early uh resuscitation for African patients uh with sepsis may, may worsen outcomes. Um Potential explanations to think about as to why this may be the case. Um may have been that malnutrition may have played a role. And so um the way that the patients are responding to, to volume they may have um uh they may have had, for example, uh cardiomyopathies associated with the malnutrition and some may have been less tolerant of, of, of fluid. Um They also may have had uh coinfections with TB and malaria that could have predisposed them to um higher chance of um pulmonary edema. Um And the fact that this was mo the majority of the patients, over 95% of these patients were uh managed on general wards rather than an ICU. Um where uh you could have had options such as CPAP to help manage their pulmonary edema or um invasive mechanical ventilation. All of these would not have been options for these patients. So, pushing them into uh worsened respiratory function, um uh may have uh improved, yeah, um increased the risk of mortality. Um Further, we also saw that the majority of these patients and this wasn't really spoken that much in the discussion of um by the author, but the majority of these patients were HIV positive and um that may also have influenced the, the results um here. Um in that uh we know that HIV can have loads of different systemic um effects on these patients, including uh cardiomyopathies. And so, um that could have potentially also played a role in making these patients far less tolerant to fluids. Um So, like I said, already, um almost a third of these patients in the sepsis protocol had to have their fluids discontinued. Um Yeah, so, um um we, we, one of the other things that I spoke about already was the issue of the JVP measurement in this, in this study which they tried to use um to as, as a surrogate for monitoring central venous pressure. Um now, already central venous pressure as a monitoring tool for fluid administration has its own issues. And so, um JVP did not really serve as a reliable surrogate for measuring CBP. And even if it had, um probably it wouldn't have been a very accurate way of um uh noting whether the patient was developing fluid overload or not. Um So the other thing in this setting was that dopamine was the only vasopressor available. And um we saw more vasopressor use in the patients who are in the in the um sepsis protocol group. Um Norepinephrine was not available. Um And so they use mostly dopamine for these patients. And um we know that no epi may have better outcomes and so that could have also potentially increased mortality. Um Strength of the study uh was that they did randomized um to try and balance these baseline confounds. They tried to conceal allocation uh to prevent selection bias. And um they had monitoring by an independent data and safety board which uh uh also evaluated the data when they were halfway through to see whether they um they needed to stop this trial earlier as well. Um And uh the collection of clinical out outcomes were uh done by blind by blinded study personnel limitations with that, it was a single center trial. And um uh although study enrollment was, they tried to be very fast with enrolling the patients once they did present, um these are patients who may have been really ill for prolonged periods of time before presenting to the patient. I mean to the to the, to the hospital. And so, um we know these late presentations to hospital facilities um in Africa is a particular problem and contributes to worse outcomes and, and I'm I'm not sure whether, you know, uh II imagine that in a high income setting, this is not as big of a problem um as it is here. And so this may be uh may have been another uh another problem which is a lot of the patients were presenting with really quite advanced sepsis. Um Um Another limitation was that the patients and clinicians and uh some of the study personnel were not blinded to the group assignment. Um The protocol relied on determination of JVP, which I thought was a weakness and um they also did multivariable analysis using the AP S3, which has not been validated um in or in, in Africa at the time or in this particular population. And also, like I said, only one of the 209 patients in this study actually made it to the ICU. The rest of them couldn't get into the ICU because of space limitation. So, in conclusion, um um basically adults with sepsis and hypotension, um most of whom had HIV in this resource limited setting um had worse outcomes if uh they had this early go directed uh therapy given to them. So the more fluid they received early on um increased um their risk of mortality uh in the first few days as well as um uh their 28 day mortality um amongst all the subgroups essentially. Um But further studies will undoubtedly be required to um see exactly how um early goal directed therapy in our setting, um, uh would influence care or outcomes. Um, uh I think one of the things to note from this study is that, um, the majority of the patients, like I said, over 90% had HIV, but the majority of people within the country do not have HIV. And so, um, I think it would still be important uh to have more studies in um, an HIV, negative um population to know whether uh this would be something that would help or not help in our setting. Those are some of the references. Um And I guess I'll hand it back over to Jan now. Thank you. Yeah. Hello. What an amazing talk um from Doctor Ken. Um I will keep my questions to the end because I think that just keeps everything fun. I don't wanna count how many me there are on the screen at the moment. Um Max. So, uh Elias Kambale from Uganda has asked, um, do you think the results of this study can be generalized to all sepsis patients uh in the hospital given that most of the patients who have HIV, as well as there's a question before? And so do you, um did this study clearly define what has been done as treatment versus usual care and how do they define usual care? Yeah. Um So II think it's very difficult to generalize it to the, to the rest of the population because um, and to all patients with sepsis because, like you rightfully said, over 90% had HIV. And, um, it's difficult to, to, from this study alone to say what the effect would have been in a completely HIV negative, um, uh, population. They may have found like other more recent trials have found that, um, early resuscitation, um, maybe just didn't affect outcomes at all but didn't necessarily, um, worsen it. Uh, but in this case, it absolutely did worsen it. So I think, um, that it's, it's, it's not Generali to, um, to all patients with, with sepsis. And I think that an individual approach needs to be taken with, with all, with all, uh, patients with sepsis and maybe, um, giving, giving smaller boluses and assessing for uh fluid responsiveness. And, um, m might be a better, um, approach than, um, just aggressively treating with, with, with fluids. Um, surgeon. Was, was they something, uh, what or how they defined usual care? Uh, usual care was, um, was pretty, uh, variable because different clinicians could do different things. But generally they found that when they, when, when usual care was applied, um, most of the patients got very little fluid, almost none of the patients got a bolus of fluids. Um, um, instead they, they tended to get, um, in the sepsis protocol. They got about 4 L. By the time it was six hours on the usual care group, they, they, they got, uh, less than half of that by the time they were six hours in and um, by 24 hours, the usual care group only had received, um, at most, around 3 L were, were prescribed. So the usual care group tended to be a lot more dry, I would say than, um, than the uh sepsis protocol group where they were a lot more aggressive with, with fluids. This reminds me about the COVID times when there were a lot of papers churning out and keeping COVID patients dry, keeping COVID patients a bit more on the, on the uh flu overload side, it was really um I think when once you have sepsis in a banner and the whole cascade comes along, I think as we learn, if not and not anything from the COVID pandemic is actually everyone's inflammatory response is actually very different um to either surgical or infection and such. So I wonder how as we move into precision medicine, maybe we'll find it will become a bit more protocol in terms of this pathology probably should be this and that pathology, you should be there. But I am sitting in my high chair and not being a researcher. So I don't know how they're gonna um run uh research like that, but it's just a point of thought. But II really enjoy, enjoy what you said. So Julia has some questions um of which, you know, actually Jules asked. Uh do you think there is something to be said about these patients being given large volumes of fluid and most active drugs on nonmonitored settings, um, which you have answered a bit about that already, I think. Um, yeah, although II II do think for sure, um, that, that could have contributed and, um, I guess that's the still the reality of, uh, care in our setting is that a lot of the times, um ICU space is going to be limited. Um, I think U th currently has an ICU, the adult section of it has an ICU capacity of around 15. If I'm not mistaken, I think they're trying to expand that a bit more. But um it's a massive hospital. And um so you're, you're going to get loads of patients who can't make it on to the ICU but require um basal vasopressors. And so in the sepsis Protocol group, they did have a higher percentage of them being given. Um uh presses and the monitoring. Um They did have a dedicated nurse to monitor every hour. Um But II think that um it definitely could um worsen outcomes if you're gonna be given and maybe probably does still in uh on our warrants if you're giving presses uh completely uh monitored or um monitored every six hours, which many of the times is, is the case here? Cool. Uh Aisling Barry asked. Um Thank you so much for talking us through the study. You said the most uh common source of sepsis in this population was chest infection do you know how this compares to other studies, which showed a better response in large volumes of fluid? Uh, yeah, that's, that's an interesting one. II think, uh, in, in this setting I haven't seen, uh, other studies around Africa and Zambia specifically, um, where the source of sepsis was, was, um, majority something else. Um, and how that related to, to outcomes. But, um, I'd, I'd have to look in the high-income, uh setting and see what the majority of the cause of sepsis was and, and see in the Rivers trial, um I'm trying to, I can't quite remember what the majority of the uh of the sepsis was caused by there. Um I'll have to look at that and see that's the one that comes to my, to my head of uh first as, as one where they saw a benefit in, in giving an early go directed therapy. So I have to look at that real quick and see what the, what the cau the major cause of sepsis was in that population. Cool. No problem. Um That's absolutely fine. Um My other question. Um It's a simple one to you that uh or you can make it however difficult it is for yourself. Um After reading this paper, Mac, has it changed any of your practice? And if so how, um I think it, it has uh because um I think prior to this, I'm was a yes and no to something I think I, I'm just a little bit, maybe a little bit more cautious in my head about how much um fluid I'd be given to these patients. But already it was um on the ICU would be uh trying to use the surviving sepsis uh bundles and um and guidelines and that 30 mil per kilo, uh bolus thing was would be something that we're thinking about. And um I II think generally the way that we've administered that is in smaller chunks, maybe 5 to 10 mils per kilo and see how the patient responds. Also using things such as like passive leg raise tests to see um whether the patient might be volume responsive. Um But I think all in all it, it maybe will just make me a little bit more cautious in, in how much fluid I'm um administering to these patients, especially in our HIV um uh positive population. That's great. Wonderful. Let me have a quick peek at the chats again. Oh, my chats have gone anyone else? Oh, that's one more, I think. Well, interesting. Well, Mack is learning Jules said, uh think this trial makes a good argument of uh how useful bedside echo and lung ultrasound might be in this setting. What are your thoughts? Mac with you and your best friend? Butterfly? Yeah, I II completely agree. II think uh point of care ultrasound on the ICU is something that's been un massively underutilized in, in my setting at the least. And there's, there's big efforts to um to get this, to get more of this done and to get uh training. We, uh for example, we recently got a very generous donation um through um through gas. And um we've been using that uh ultrasound to do point of care, ultrasound um to do things such as lung scanning and, and echoes and, and things like that. And it's helping us make decisions on, on, on patients. We, we're also setting up more seminars now. Um I think we have one coming up in the next few days um uh on point of care ultrasound. So this is a skill that we're trying to, to, to learn and uh to give um people over here to help make decisions. So, yeah, great thoughts on that. Absolutely amazing. Are there any more questions coming along? Um Do you have any questions for us? Mark? Actually, I never got up questions from the speakers, but do you have any questions and make um you wanna know, let me know. II see, I see someone said uh why did they use 4 L of fluid? Um Well, this was um they looked at how much was being given in, in other trials and the other other trials in a six, in a six hour period had actually given more. Um But because they had had experience um from the previous trial that I spoke about, which was also done at T th uh which was stopped early because of um bad outcomes in patients who already had hypoxemia and um who already had hypoxemia and uh uh tachy, they decided to lower the, the, the volume by around 2 L to 4 L. And, and so that's how they uh decided to try and use, use that the river, which did show benefit at a much higher um volume than this. Absolutely amazing. I have seen people giving uh so much fluid in our sepsis patients um had to stop them. Um I think most recently in 2021 sep surviving surviving sepsis campaign, I think the I need to look into the evidence base, but the national guideline has recently said once you've got over 40 mils per kilogram, uh you probably should stop and you should start vasopressors. Um And the vasopressor of choice is noradrenaline. Now, um that is very different in the pediatric population because we do uh we do peripheral noradrenaline. Um but that is by and large where the current uh research evidence is driving and the national guidelines are at the moment, whether how much of that has filtered down to our registrars and our Sh OS and carrying out. I'm not even sure because one of the previous doctor have said like from bench to bench er from bench to clinical that takes at least 10 years um before anything is filter done. So we'll see how this goes, but we are great people that we keep ourselves up to date. So, um we'll, we'll keep going and singing the praises. Now, let me just double check if there's any more um charts. I don't think so. I'm afraid we might have to release you back to your on call a little bit earlier. Ma I'm so sorry. Um But thank you so, so much for being here. Um Before people please don't go, we've still got one more surprise speaker for you guys. Um But ma uh you will get an automatically generated um faculty certificate um for the audience here. So long as you filled out our um our uh evaluation form, once you press enter and that will give you an automatic er certificate er from there onwards. So please don't forget to do your feedback form and this er, today's er journal club has got the Royal College of initiatives, UK CPD of 1.5 points. So that's absolutely amazing. So, Mac uh feel free to say if you want to, but I know you have your call and I don't want to stop your emergency theater for you not being there. Um But sorry. Yeah, until I next see you, but uh all the best. See you right. Take care. Yeah, thank you. See you. Thank you. See you. So our next speaker, um our surprise small speaker, small speaker, I say small, our surprise small presentation speaker is er, Doctor Bath or Mr Bath. Rather Mr bath who's a general surgery registrar in London. He's a phd student in International Health Systems Group at the University of Cambridge. He is one of the lead Maria, your, your questions to let you go and ask Mack yourself. Um He's a phd student in International uh health Health Systems Group in University of Cambridge. I think it's the same group as Tom Bashford, which is a dear friend of ours. Um Tom is so funny. Um He's the lead investigator for Gold Trauma study. Um So Gasso um currently hold a, I think, support a collaborator role with the Gold Trauma study. So um please stay, er, keep your ears peeled and see how you can help. Cos I think this is an international study. Um So without further ado I will give you the stage, Maria, I'll talk to you in a moment. All right. Thank you very much. Thank you so much Jan for that. Um And thank you for the time. Uh giving me the opportunity to, to speak. Uh The Gold Trauma Study is a new and new and upcoming trauma study. So it's nice to have two presentations on one very well. Uh well founded paper, then the new uh the pediatric study that's come out. So now on the next stage of that all sort of the earlier stages, our Gold Trauma study, um I did have slides, I don't know if we were able to put them up. Is that possible Yeah, that's fine. I'll do that for you. Thank you so much. Um, so as Jan said, my name's Mike, I'll be very quick. I know we've had a very long and, er, productive session, so I'll be very quick. Um, before we all shoot off. Um, I am indeed a surgical registrar from London, but I'm also a phd student, er, working with Tom Bashford, er, group in the University of Cambridge and we are, er, running a global trauma laparotomy study called Gold Trauma. Um, the, which the sliding will come up there. It is great. The Gold Trauma study. So that stands for global outcomes after, er, trauma lap, er, er, after laparotomy for trauma. Uh, next slide, mind control or both. So we've got lots of support for this study. Um, you can see that gas O is there, however, we've had fantastic support already from trauma groups in the UK, in, er, in North and Latin America, er, the European Society of Trauma Surgery got involved and Cambridge Public Health and our Global health research group, er, on brain and spine injuries have also been supporting this next line. So I appreciate, I'm speaking to speak to you. What much of, you know, anyway, but why are we doing this study where we know the burden of trauma is very, er, is very large across the globe? 10% approximately of all deaths that occur are wider due to trauma that equates to about 5 million people per year, we could save around 2 million lives if we were to standardize and improve that care across the board. And why is trauma also important? Well, it does affect er, young individuals predominantly. And so there becomes almost an economic argument as well that it is the disability that comes with traumatic care as well as these high mortality rates. I'm in the Systems, er, design group in the University of Cambridge. And our work is trying to better understand how to design these trauma systems. Next slide please. And what, how we're trying to better understand this is using the trauma laparotomy is almost a surrogate marker of trauma care in this trauma system. Someone who requires a trauma laparotomy hits all the areas of a trauma system as it passes through regardless of the setting that you're in. Um And so trying to use this as a to biopsy and unpick that trauma journey that your patients have give us a much richer picture of what's going on as the numbers say there, mortality rates are very high following a trauma laparotomy. Um And this is really in both low and high income settings um and low resource and high resource settings. Uh And despite um standards of care improving, these are still remain significantly um er simply high mortality rates. Next slide, please. So the this work has been based on um multiple er other research projects. Many of you will know um the, the global surge group we've been working closely with so have been doing this work, um, er, in their work in both elective and emergency general surgery. The TA group have been working, we've been working with from Queen Mary's and they ran a trauma laparotomy study in the UK back in 2019 2020 which showed that there is variation across the world, but this was a one country study, how current rates of trauma care, er, vary across the world still remains elusive. Now, our group has previously run the genos study, um which um er was er a global study looking at traumatic brain injury care and did unpick some important points. But clearly, neurotrauma care is often a tertiary level service. It's often quite a specialist service and we need to be better understanding what the vast majority of trauma care can be seen across the world. As I said before, we're using the trauma laparotomy to biopsy that next slide, please. So this brings us to the Gold Trauma study. So we are looking to evaluate the patients and the injury factors of all of those that go undergo a trauma laparotomy, the management that they get and their outcomes and really trying to unpick that pathway to see well, what the, what the systems issues that are, are occurring here. Where are the, where are the barriers to care and um where, where can we improve? Now, this study has been developed with er, anesthetists, with surgeons with intensive care, doctors, with emergency medicine, doctors from across the world and developing our protocol. And hopefully we'll the data points that we collect and we'll unpick this more next slide, please. The study design. So we are running a similar to what was presented earlier with the Asos Peds trial. We are running a observational Multicenter International cohort study. We're including patients of all ages who have present to hospital with any type of traumatic injury. So that's blunt or penetrating, who undergo a trauma laparotomy within five days um of presenting to that hospital and we're collecting data from across the pathway. So from the time of injury through to their time of discharge, we've already piloted this work in Cambridge and in Kampala. Um and er, Eth, whilst we have got ethical approval from the University of Cambridge, we would, we, the recruiting sites will also get a local approval as well. Next slide, please. So I'm just gonna post in the chat now, the er, website for um er to go to, to learn more information about it, including our protocol that you can see here. Now, I've put it in French because we have translated the study protocol into multiple languages in, from French, Italian, er, Spanish, er Russian and Mandarin. Next slide please. We, we're using the redcap um er platform that many of you maybe use with for a very secure er data collection tool and each collaborator involved will not only be part of a uh a PUBMED site, collaborative authorship but will also get access to the University of Cambridge Library Library Services, which I think is a fantastic opportunity. And um er addition that we can provide those who get involved next live please. The protocol will give more detail to it but here's some of the data points er that were involved. Er and as I say, we've collected it from the admission, the operative and the post operative outcomes, er both anesthetic and surgical and perioperative er factors. There. Next slide please. And I mentioned before that we're in the trauma, er we're in the system design group and I think one key aspect of this which sets our this study apart is that we're really trying to better understand the trauma system design that er is is involved. This is not in my view, not just a simple epidemiological study. We really want to unpick some of these systemic factors that, that really play a part of the trauma, trauma patient pathway. Looking at one point here is just a timeline of what we wo of injury for some of these patients. So we're looking at the time of injury through to the time they get to hospital when the decision to operate was when the decision the operate. So when the operation actually started and when they were discharged and within that there's a lots of nuance that can really be picked up from that next lab, please. I mentioned a few of these before. What, what can uh we offer you as collaborators to get involved? Well, already, we've had interest from over 200 centers and we've had centers from er across the world er formally sign up to the study to be part of a growing trauma research collaborative. I mention our collaborative authorship model um but also you'll be able to download your own hospital level data um for for local service improvement. And I mentioned also about the access to the Cambridge University Library services. Should you get involved? Next slide, please? For those interested, please email our team or visit us at the website to sign up. Um The study does start in April. However, we're accepting new centers all the time and um we're very keen to engage with as many people as we can to really build that rich picture of what trauma care looks like across the world and what how trauma systems can really be developed. Um As I say, more detail can be found on our website. I'm keen to hear any questions you may have and uh please let me know er and get in contact. Um Should you wish to get involved? Thank you for your time. Hello, one quick question. Um If I may uh more just because Bruce talked about it. Um How are the collaborators acknowledge uh in in um publication because your truly I'm sorry, uh sit on a journal board and we talk about that a lot in terms of how uh how are our low resource country colleagues acknowledge in terms of spreading of authorship as well as uh collaborations and spreading of first and last authorships to be fair. Um So what, how, how is that envisage in your study? Yeah. You know, it's a really important point that we make sure we have been been addressing throughout. Now, I did mention we're doing a collaborative authorship. So every collaborator will be cited on the work as a PUBMED cable author. However, our the the main thing I could say is our steering, our steering committee and our advisory committee have been made up of individuals from across um the er from across the world. We've got emergency medicine doctors from Mexico, we've got intensive care doctors from Uganda, we've got general surgeons from Ghana. Um So we really as well as colleagues in the US and the UK. So we've really, we try to build up as much of a er er a um international group as well. When it comes to writing up the final study, you made an excellent point about first author, authors and last authors making sure where there is appropriate representation in those positions is key. And it was, you mentioned, Tom, it was something that we were literally talking about the other day to make sure this this is a priority. The final thing and I know I mention it again, but I just think it's a really good thing that I don't think many other centers give that many other studies could do. Being able to offer access to the Cambridge Library online services with articles. Uh I think is a really big thing for, well, I like to think is a big thing for the study and something we can offer all collaborators. If they want to get involved, they can download journal articles. Um, if accessible are all I care is if I can get the newest and Jama from those, because some of the NHS libraries don't, they have to borrow it from the other libraries. I'm like, no, no, thank you. Um, anyone in the audience will have any questions on that before I hijack the whole thing about chatting about authorships. Um, I just had a quick question. Is it just trauma centers in the UK or any hospital? Because obviously in like a little d DH a trauma laparotomy is pretty rare? Yeah. So, yeah. No, it's a really good point with any hospital. And we say that to be involved in authorship, you have to recruit one trauma laparotomy in a 30 day um, window. However, if you do a 30 day window and you don't have any trauma laparotomies, you can just roll it over to the next 30 days, we'll try and be as flexible as we can. And it's a really important point that you raise that district generals in a way are kind of who we want to get. Certainly, uh, they're, they're equally, if not more important sometimes than these major trauma centers. Certainly in less developed regions. We know that is often where the, the trauma goes to. So trying to unpick, unpick that away from the tertiary level centers, going back to these, er, district generals um, is really key. So we can any hospital that as long as they do uh general surgery there is involved? Cool. Thank you. Cool. Any other questions anyone has questions? Well, thank you to, er, thanks er, gas up for supporting the study as well. I really appreciate your support. It's great to have you guys supporting it and thank you for letting me speak today. It's wonderful. We'll keep in touch, don't worry. Um, but thank you so much for coming. Um If they have any questions, can you put your email down? Wonderful. Thank you. Thank you so much. I'm sure I see you around in the London Theaters. Thank you very much Claire. I think we're done, aren't we? We are. Thank you everyone for attending. We have a day until the end. Um the feedback um link will auto um be sent to you. So if you fill that in as soon as you can, you'll get your certificate just because the longer you leave it, the more likely you have to get to do it. Um it was great to see you all. Thank you very much for coming. Our next general club will be surgery themed and in April, which we're just um picking the date for. So we'll update you all once that's chosen any other not done. No, stay tuned for everything. Um A lot of collaborations go on to a website to see things. Um If you guys have any other questions, there are, yeah, there are lots of opportunities in gas do just give us a shout. All the emails are on the website. Um So yeah, that's basically it. Perfect. Stay tuned. Thank you, everyone. Thanks. Take care. 01 more thing just wanted to shout out in the audience. I saw one more committee member. I think I saw Fiona and she's the other UK anesthetic rep um in the audience. Um She's been also crucial in making this happen as well. Um So I couldn't do it without her. So that's it. Really. Thank you, everyone. Take care. Bye bye. Thank you Claire.