BJA open最新文献

{"title":"Evaluating the risks and benefits of continuing versus withholding renin–angiotensin system inhibitors: a systematic review and meta-analysis with trial sequential analysis","authors":"Laila Shalabi ,&nbsp;Ahmed Ibrahim ,&nbsp;Sofian Zreigh ,&nbsp;Mohamed Rifai ,&nbsp;Shrouk Ramadan ,&nbsp;Mohamed A. Arafa ,&nbsp;Osama M. Mustafa ,&nbsp;Muhammad Ansab ,&nbsp;Mohamed F. Krayem ,&nbsp;Ibrahim Elsabbagh ,&nbsp;Nour H. Mash’al ,&nbsp;Salem Waleed ,&nbsp;Matthieu Legrand","doi":"10.1016/j.bjao.2025.100405","DOIUrl":"10.1016/j.bjao.2025.100405","url":null,"abstract":"<div><h3>Background</h3><div>The best perioperative management of renin–angiotensin system inhibitors (RASi) in patients undergoing noncardiac surgery has been an ongoing debate as a result of inconclusive previous studies and insufficient data for robust guidelines. Although continuation of RASi may lead to intraoperative hypotension, withholding might also cause postoperative complications. Our meta-analysis aims to explore the postoperative outcomes of strategies of RASi management before surgery by evaluating randomised clinical trials, to provide more definitive conclusions for clinical practice.</div></div><div><h3>Methods</h3><div>We systematically searched PubMed, Scopus, Cochrane, and Web of Science until September 2024. Inclusion criteria included patients (≥18 yr) who underwent noncardiac surgery and received long-term RASi, which were either withheld or continued before surgery. Statistical analysis was conducted using R Studio version 4.4.2.</div></div><div><h3>Results</h3><div>A total of seven RCTs with 8741 patients receiving long-term RASi before noncardiac surgery revealed no significant difference between continuation and withholding groups regarding cardiovascular complications (risk ratio [RR] 0.94, 95% confidence interval [CI] 0.80–1.09, <em>P</em>=0.41), mortality (RR 1.16, 95% CI 0.55–2.43, <em>P</em>=0.71), and acute kidney injury (RR 0.95, 95% CI 0.84–1.06, <em>P</em>=0.33). However, continuation of RASi was associated with a higher incidence of intraoperative hypotension (RR 1.33, 95% CI 1.23–1.44, <em>P</em>&lt;0.001). Additionally, the incidence of postoperative severe hypertension (systolic BP &gt;180 mm Hg) was significantly lower in the continuation group (RR 0.63, 95% CI 0.40–0.98, <em>P</em>&lt;0.002).</div></div><div><h3>Conclusions</h3><div>Continuing RASi before noncardiac surgery does not significantly impact mortality, cardiovascular complications or the risk of acute kidney injury. However, continuation is associated with an increased risk of intraoperative hypotension, and withholding with a higher risk of postoperative severe hypertension.</div></div><div><h3>Systematic review protocol</h3><div>CRD42024605208 (PROSPERO).</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100405"},"PeriodicalIF":0.0,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143898483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Common pitfalls of perioperative clinical trials in response to ‘Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial)’","authors":"Tori N. Sutherland ,&nbsp;Paul A. Stricker ,&nbsp;Andrew J. Davidson","doi":"10.1016/j.bjao.2025.100409","DOIUrl":"10.1016/j.bjao.2025.100409","url":null,"abstract":"<div><div>In this issue, Hyslop and colleagues discuss challenges leading to inadequate enrolment and premature termination of the MAGIC trial, a multicentre randomised controlled trial of melatonin <em>vs</em> midazolam premedication for anxiety among children. The authors should be commended for sharing their experiences, as they underscore common pitfalls of well-intended trials in the perioperative setting, including issues with study design and implementation.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100409"},"PeriodicalIF":0.0,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143868620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Functional coupling between chronic pain and the autonomic nervous system revealed by neuromodulation techniques. Response to BJA Open 2025; 14: 100393","authors":"Bart Billet ,&nbsp;Lisa Goudman ,&nbsp;Sören Verstraete ,&nbsp;Werner Nagels ,&nbsp;Maarten Moens","doi":"10.1016/j.bjao.2025.100408","DOIUrl":"10.1016/j.bjao.2025.100408","url":null,"abstract":"","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100408"},"PeriodicalIF":0.0,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143868621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preoperative submaximal cardiopulmonary exercise testing and its association with early postoperative complications","authors":"Zyad J. Carr ,&nbsp;Jean Charchaflieh ,&nbsp;Andres Brenes-Bastos ,&nbsp;Hugo He ,&nbsp;Hung-Mo Lin ,&nbsp;Amanda Jankelovits ,&nbsp;Emily Gu ,&nbsp;Jill Zafar ,&nbsp;Fed Ghali ,&nbsp;Wei S. Tan ,&nbsp;Paul Heerdt","doi":"10.1016/j.bjao.2025.100407","DOIUrl":"10.1016/j.bjao.2025.100407","url":null,"abstract":"<div><h3>Background</h3><div>Early postoperative complication risk prediction would enhance perioperative surveillance and resource allocation. Reports have described brief submaximal cardiopulmonary exercise testing (CPET) for the routine assessment of cardiopulmonary disease. Compared with conventional CPET, it can be performed in 6 min and is used to predict peak CPET measurements. We aimed to determine whether submaximal CPET-derived measures outperform structured surveys in early postoperative complication detection.</div></div><div><h3>Methods</h3><div>An institutional review board-approved, single-centre, open-label, clinical device trial was conducted. A total of 101 participants undergoing noncardiac surgery, aged &gt;60 yr, with revised cardiac risk index ≤2, self-reported metabolic equivalents &gt;4 (METs in ml O₂ kg⁻¹ min⁻¹; self-endorsed reliably climbing two flights of stairs), were enrolled. Participants completed a subjective METs assessment, Duke Activity Status Index, and submaximal CPET that derived peak oxygen uptake (VO₂, ml O₂kg⁻¹ min⁻¹), METs, and gas exchange-derived pulmonary capacitance (GXCAP, in ml O₂ beat^-1 kPa^-1). Elastic net regularisation machine learning identified feature importance among study measures for the primary endpoint (Postoperative Morbidity Survey [POMS] ≥1), secondary endpoints (cardiac, pulmonary and renal domains of the POMS [POMS-CPR ≥1]), and length of stay. Adjusted multivariable regression models were used to identify significance.</div></div><div><h3>Results</h3><div>Of 101 participants, 53 (52.4%) had POMS ≥1. GXCAP to peak VO₂ slope (GXCAP-VO₂) was associated with POMS ≥1 (OR_adj 0.94; 95% CI 0.89–0.99; <em>P</em>=0.011) and increasing length of stay (OR_adj 0.98; 95% CI 0.96–0.99; <em>P</em>=0.01). GXCAP-VO₂ slope (OR_adj 0.93; 95% CI 0.88–0.99; <em>P</em>=0.015) was associated with POMS-CPR ≥1.</div></div><div><h3>Conclusions</h3><div>Compared with structured surveys (subjective METs or Duke Activity Status Index) or conventional peak CPET values (VO₂ or METs), a novel measure, GXCAP-VO₂ slope, offered superior early postoperative complication discrimination in low-morbidity subjects. These preliminary findings support GXCAP-VO₂ slope as a compelling investigational target for early postoperative complication risk, supporting the use of CPET to enhance early postoperative complication prediction.</div></div><div><h3>Clinical trial registration</h3><div>NCT05743673.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100407"},"PeriodicalIF":0.0,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143868622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges in achieving more sustainable anaesthesia practices: a narrative review of waste reduction","authors":"Erlend J. Skraastad ,&nbsp;Ofelia L. Elvir-Lazo ,&nbsp;Paul F. White ,&nbsp;David Chernobylsky ,&nbsp;Ravina Brring ,&nbsp;Roya Yumul","doi":"10.1016/j.bjao.2025.100406","DOIUrl":"10.1016/j.bjao.2025.100406","url":null,"abstract":"<div><div>Anaesthesia and operating room waste contribute to climate change and environmental pollution. Although professional bodies involving anaesthesiologists and surgeons have developed guidelines for supporting environmentally conscious health practices, practitioners face difficulties implementing these protocols in hospitals. This narrative review explores the current literature concerning the environmental impact of anaesthesia and operating room waste. We also discuss obstacles practitioners face in implementing initiatives to decrease anaesthetic and surgical waste. A literature review of peer-reviewed publications was conducted across PubMed, MEDLINE, Google Scholar, and Cochrane Databases to identify relevant articles published from 1980 to 2025. A search of recent anaesthesia, surgery, and medicine journals provided additional data. Around 2% of urban solid waste is medical waste, and healthcare accounts for 5% of global greenhouse gas emissions. Scientific organisations have clearly defined guidelines and recommendations to reduce environmental impact. Barriers to implementing existing recommendations include the lack of proper facilities for recycling waste materials, provider workload concerns, lack of hospital leadership, lack of specific targets and accountability measures, insufficient education, and overall resistance to change. Anaesthetic and solid operating room waste pose significant global health concerns, necessitating a collective effort towards sustainability. Anaesthesia and operating room professionals must recognise their responsibility for promoting environmentally friendly practices. Hospital leadership is pivotal to creating a supportive framework. Hospitals and healthcare systems should be required to adhere to specific targets and accountability measures. Meaningful change requires collaboration with a wide range of stakeholders, including politicians, patients, the medical industry, and scientific organisations.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100406"},"PeriodicalIF":0.0,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143855208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The 3-Minute Diagnostic Confusion Assessment Method severity score correlates with the Delirium Rating Scale–Revised–98 and with biomarkers of delirium","authors":"Cameron Rivera ,&nbsp;David Kunkel ,&nbsp;Maihlee Her ,&nbsp;Simran Qureshi ,&nbsp;Robert A. Pearce ,&nbsp;Robert D. Sanders ,&nbsp;Richard Lennertz","doi":"10.1016/j.bjao.2025.100398","DOIUrl":"10.1016/j.bjao.2025.100398","url":null,"abstract":"<div><h3>Background</h3><div>Several methods are used to measure delirium severity in the postoperative period. Here, we compare severity scores from two common assessment methods: the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) and the Delirium Rating Scale–Revised–98 (DRS).</div></div><div><h3>Methods</h3><div>Data were collected as part of an ongoing observational cohort study of perioperative delirium in patients &gt;65 yr old undergoing major elective surgery with an anticipated hospital stay of at least 2 days. Patients were excluded if they had a documented history of dementia, resided in a nursing home, underwent neurosurgery, or could not complete neurocognitive testing. Patients underwent paired 3D-CAM and DRS assessments before and after operation along with EEG, cognitive testing, and plasma biomarker analysis.</div></div><div><h3>Results</h3><div>Of 226 subjects enrolled, 204 completed both the 3D-CAM and DRS assessments. Peak 3D-CAM severity (3D-CAM-S) scores correlated with peak DRS severity scores, for both the raw (ρ=0.74, <em>P</em>&lt;0.001) and short form method (ρ=0.66, <em>P</em>&lt;0.001). Peak 3D-CAM-S raw scores also correlated with delirium duration and severity duration area under the curve measures (ρ=0.71, <em>P</em>&lt;0.001 and ρ=0.91, <em>P</em>&lt;0.001, respectively). Similar to prior reports with the DRS, 3D-CAM-S raw scores correlated with worse performance on the Trail Making Test B (ρ=0.37, <em>P</em>&lt;0.001, <em>n</em>=177), slow-wave electroencephalogram power (ρ=0.3, <em>P</em>=0.001, <em>n</em>=73), and plasma neurofilament light (ρ=0.26, <em>P</em>&lt;0.05, <em>n</em>=61) and tau (ρ=0.41, <em>P</em>&lt;0.001, <em>n</em>=63).</div></div><div><h3>Conclusions</h3><div>The 3D-CAM-S severity scores correlated with DRS, delirium duration, and biomarkers of delirium. The 3D-CAM, which is easier to implement than the DRS in postoperative patients, may provide a comparable assessment of delirium severity in this population.</div></div><div><h3>Clinical trial registration</h3><div>NCT03124303.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100398"},"PeriodicalIF":0.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143851760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in paediatric anaesthesia research publications and the impact of author sex, country of origin, topic, and external funding","authors":"Andy Jeon ,&nbsp;Aine Sommerfield ,&nbsp;Britta S. von Ungern-Sternberg","doi":"10.1016/j.bjao.2025.100397","DOIUrl":"10.1016/j.bjao.2025.100397","url":null,"abstract":"<div><h3>Background</h3><div>The current research landscape has become increasingly competitive with approximately 35% of submitted manuscripts accepted for publication by peer-review journals. It is known that studies with certain ‘favourable characteristics’ have an increased likelihood of acceptance for publication, such as prospective study design, multiple sites, and notable authors.</div><div>We aimed to identify the characteristics of original research publications in paediatric anaesthesiology and the impact of these characteristics on citations. The characteristics selected were study design, topic choice, region of origin, sex of authors (as defined by first name), and presence of external funding.</div></div><div><h3>Methods</h3><div>This bibliometric study reviewed all paediatric anaesthesiology original research articles published between 2012 and 2021 from five high-impact general anaesthesiology journals and from the subspecialty's top-ranking specialist journal, <em>Pediatric Anaesthesia</em>. Original research articles (<em>n</em>=1119) were independently assessed by two investigators for the following characteristics: primary research topic, study design, region of origin, number of sites involved, external funding status, sex of first and last author, and number of citations.</div></div><div><h3>Results</h3><div>The principal findings in our study showed that highly cited articles in paediatric anaesthesiology were more likely to display publication characteristics such as prospective study design (66% <em>vs</em> 61%), multi-site (23%% <em>vs</em> 14%), and being externally funded (53% <em>vs</em> 46%).</div></div><div><h3>Conclusions</h3><div>Our report highlights the need to consider consumer priorities for research, to encourage collaboration across institutions, and to generally improve access to funding for paediatric anaesthesiology research. In addition, the findings underline the already recognised need to reach better sex equality in academic paediatric anaesthesiology publications.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100397"},"PeriodicalIF":0.0,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143830121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploratory randomised trial of tranexamic acid to decrease postoperative delirium in adults undergoing lumbar fusion—a trial stopped early","authors":"Bradley J. Hindman ,&nbsp;Catherine R. Olinger ,&nbsp;Royce W. Woodroffe ,&nbsp;Mario Zanaty ,&nbsp;Carolina Deifelt Streese ,&nbsp;Zeb R. Zacharias ,&nbsp;Jon C.D. Houtman ,&nbsp;Linder H. Wendt ,&nbsp;Patrick P. Ten Eyck ,&nbsp;Debra J. O'Connell-Moore ,&nbsp;Emanuel J. Ray ,&nbsp;Sarah J. Lee ,&nbsp;Daniel F. Waldschmidt ,&nbsp;Lauren G. Havertape ,&nbsp;Lanchi B. Nguyen ,&nbsp;Pei-fu Chen ,&nbsp;Matthew I. Banks ,&nbsp;Robert D. Sanders ,&nbsp;Matthew A. Howard III","doi":"10.1016/j.bjao.2025.100403","DOIUrl":"10.1016/j.bjao.2025.100403","url":null,"abstract":"<div><h3>Background</h3><div>Postoperative delirium may be mediated by systemic inflammation and neuroinflammation. By inhibiting the proinflammatory actions of plasmin, tranexamic acid (TXA) may decrease postoperative delirium. To explore this hypothesis, we modified an ongoing randomised trial of TXA on blood loss, adding measures of delirium, cognition, systemic inflammation, and astrocyte activation.</div></div><div><h3>Methods</h3><div>Adults undergoing elective posterior lumbar fusion randomly received intraoperative i.v. TXA (<em>n</em>=43: 10 mg kg⁻¹ loading dose, 2 mg kg⁻¹ h⁻¹ infusion) or placebo (<em>n</em>=40). Blood was collected before surgery and 24 h after surgery (<em>n</em>=32) for biomarkers (cytokines and S100B). Participants had twice daily delirium assessments (<em>n</em>=65). Participants underwent four measures of cognitive function before surgery and during post-discharge follow-up.</div></div><div><h3>Results</h3><div>Postoperative blood loss was ∼38% less in the TXA group compared with the placebo group with medians of 128 and 207 ml level⁻¹, respectively, <em>P</em>=0.013. Total blood loss in the TXA and placebo groups did not differ with medians of 305 and 333 ml level⁻¹, respectively, <em>P</em>=0.472. Delirium incidence in the TXA group (7/32=22%) was not significantly less than in the placebo group (11/33=33%); <em>P</em>=0.408, effect size =–0.258 (95% confidence interval –0.744 to 0.229).</div></div><div><h3>Conclusions</h3><div>A potential 33% relative decrease in postoperative delirium incidence justifies an adequately powered clinical trial to determine if intraoperative TXA decreases delirium in adults undergoing lumbar fusion.</div></div><div><h3>Clinical trial registration</h3><div>NCT04272606.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100403"},"PeriodicalIF":0.0,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143825970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A bundle to prevent postinduction hypotension in high-risk noncardiac surgery patients: the ZERO-HYPOTENSION single-arm interventional proof-of-concept study","authors":"Kristen K. Thomsen ,&nbsp;Alina Kröker ,&nbsp;Linda Krause ,&nbsp;Karim Kouz ,&nbsp;Christian Zöllner ,&nbsp;Daniel I. Sessler ,&nbsp;Bernd Saugel ,&nbsp;Moritz Flick","doi":"10.1016/j.bjao.2025.100392","DOIUrl":"10.1016/j.bjao.2025.100392","url":null,"abstract":"<div><h3>Background</h3><div>Postinduction hypotension is common and associated with organ injury but might be largely preventable by careful anaesthetic management. We thus aimed to quantify the severity and duration of postinduction hypotension in high-risk noncardiac surgery patients treated with a hypotension prevention bundle.</div></div><div><h3>Methods</h3><div>In this prospective single-arm interventional proof-of-concept study, 107 high-risk noncardiac surgery patients were treated with a hypotension prevention bundle. The bundle included continuous intra-arterial blood pressure monitoring, a hypotension alarm set at a mean arterial pressure (MAP) of 75 mm Hg, careful administration of anaesthetic drugs, and continuous administration of norepinephrine when MAP decreased below 75 mm Hg. The primary endpoint, AUC65, was derived from a plot of MAP over time for the first 15 min after induction of general anaesthesia as the area of the plot under a MAP of 65 mm Hg .</div></div><div><h3>Results</h3><div>Of 107 patients, 55 (51%) had at least one MAP reading &lt;65 mm Hg, but only 16/107 patients (15%) had a MAP &lt;65 mm Hg for at least one continuous minute. Patients had a MAP &lt;65 mm Hg for a median (25% percentile, 75% percentile; minimum–maximum) of 0.2 min (0.0, 0.8; 0.0–5.2 min). The median AUC65 was 0.1 mm Hg . min (0.0, 4.1; 0.0–40.6 mm Hg min).</div></div><div><h3>Conclusions</h3><div>We observed minimal postinduction hypotension in high-risk noncardiac surgery patients treated with a hypotension prevention bundle. However, randomised trials are needed to confirm that using the hypotension prevention bundle helps reduce postinduction hypotension.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100392"},"PeriodicalIF":0.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143817607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PErioperative respiratory care aNd outcomes for patients underGoing hIgh risk abdomiNal surgery (PENGUIN): a randomised international internal pilot trial","authors":"PENGUIN Trial Management Group","doi":"10.1016/j.bjao.2025.100396","DOIUrl":"10.1016/j.bjao.2025.100396","url":null,"abstract":"<div><h3>Background</h3><div>Infections are a common complication of abdominal surgery in low- and middle-income countries (LMICs). The role of a high fraction of inspired oxygen (FiO₂) and chlorhexidine mouthwash in preventing post-operative infections is unconfirmed.</div></div><div><h3>Methods</h3><div>Internal pilot phase of an international outcome assessor-blinded, 2x2 factorial randomised trial of patients aged ≥10-years undergoing midline laparotomy in LMIC hospitals. The main trial objectives are to compare the clinical effectiveness of preoperative 0.2% chlorhexidine mouthwash in preventing pneumonia versus no mouthwash, and 80–100% perioperative FiO₂ to prevent surgical site infection (SSI) versus 21–35% FiO₂. This 12-month internal pilot assessed feasibility of hospital site opening, patient recruitment, intervention adherence, patient follow-up and safety. Patients were randomised in a 1:1:1:1 ratio to the four intervention group combinations and followed up for 30 days.</div></div><div><h3>Results</h3><div>We recruited 927 patients from seven hospitals in India and South Africa over 12 months from November 2020. There were 907 adults (97.8%) and 20 children aged ten or over (2.2%): 89/927 (9.6%) patients died. Site opening reached 70% of our target (7/10) hospitals, and patient recruitment 107% (927/870). 917/927 (99%) patients in the mouthwash arm, and 840/927 (91%) patients in the oxygen arm received the allocated intervention. Lower adherence to the oxygen intervention related mainly to clinically necessary FiO₂ increases in the 21–35% FiO₂ arm. 30-day follow-up was completed appropriately for 924/927 (99%) patients. and was performed by a masked assessor for all patients. There were no reported safety events.</div></div><div><h3>Conclusion</h3><div>This pilot showed the feasibility and safety of a major phase III trial in post-operative infection prevention in LMICs.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov NCT04256798.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"14 ","pages":"Article 100396"},"PeriodicalIF":0.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143808144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}