Acta Anaesthesiologica Scandinavica最新文献

{"title":"Severity of Illness and Mortality According to Time of Admission to Intensive Care.","authors":"Ville Ihalainen, Anssi Pölkki, Stepani Bendel, Johanna Hästbacka, Sirkku Heino, Matti Reinikainen","doi":"10.1111/aas.70229","DOIUrl":"10.1111/aas.70229","url":null,"abstract":"<p><strong>Introduction: </strong>Staffing at hospital wards is at its lowest during nighttime, which may endanger prompt recognition of the need for intensive care. High severity of illness of patients admitted to the intensive care unit (ICU) in the morning may reflect delayed referral for intensive care during the night. We investigated whether severity of illness at ICU admission is dependent on admission time.</p><p><strong>Methods: </strong>We analysed data from 25 Finnish ICUs between 2005 and 2022, utilising the national ICU registry. We excluded readmissions, children, non-emergency admissions, cardiac surgery patients and patients admitted for the purpose of organ donation. We explored the severity of illness, as quantified with the Simplified Acute Physiology Score (SAPS) II score, and in-hospital mortality according to admission hours. We also conducted linear and logistic regression analyses adjusting for age, sex, admission type, source of admission, diagnosis category and severity of illness.</p><p><strong>Results: </strong>The study population comprised 131,175 ICU patients. The mean (± SD) SAPS II score at admission was 37.9 ± 17.4, and overall in-hospital mortality was 14.7%. The mean SAPS II score was 39.0 ± 17.9 for morning admissions (6-12 a.m.) and 37.6 ± 17.2 during other times (p < 0.001). The corresponding in-hospital mortalities were 17.5% and 13.9%, respectively (p < 0.001). After adjusting for differences in patient characteristics, morning admissions remained independently associated with higher SAPS II score (mean difference 0.87 points, 95% CI, 0.65-1.09) and in-hospital mortality (OR 1.17, 95% CI, 1.13-1.21).</p><p><strong>Conclusions: </strong>Patients admitted to intensive care during morning hours experienced higher severity of illness and higher in-hospital mortality.</p><p><strong>Editorial comment: </strong>This analysis, from the national ICU database in Finland, shows that cases with morning admission to the ICU appear to have more severe illness compared to those admitted at other times of day. The authors consider if there might be some nighttime delay for recognition of ICU need which could contribute to this observation.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70229"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13021569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147519901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Influence of Profession, Experience and Geographical Region on Intra- and Postoperative Opioid Practice in Denmark: A Post Hoc Analysis of the OPIAID Survey.","authors":"Trang Xuan Minh Tran, Mik Wetterslev, Anders Kehlet Nørskov, Christian S Meyhoff, Markus Harboe Olsen, Theis Skovsgaard Itenov, Ole Mathiesen, Anders Peder Højer Karlsen","doi":"10.1111/aas.70222","DOIUrl":"10.1111/aas.70222","url":null,"abstract":"<p><strong>Background: </strong>Clinicians often administer opioids to manage postoperative pain, but with considerable variation in chosen opioid and dosing strategies. This post hoc analysis of a Danish nationwide survey assessed how profession, length of experience, and geographical region impact dosing in the intraoperative phase (end of surgery) and the postoperative phase (PACU) for postoperative control.</p><p><strong>Methods: </strong>A 37-item online survey on opioid practice amongst anaesthesia personnel in Denmark (5 February-30 April 2024). Regression analyses compared intravenous morphine equivalent doses (MEQ) in eight clinical cases for three provider characteristics: profession (physician/nurse), length of experience (> < 10 years) and geographical region (five regions). We predefined differences ≥ 0.03 mg/kg MEQ as clinically relevant. We qualitatively described group differences in perioperative factors guiding dose adjustments, defining differences ≥ 10% as relevant.</p><p><strong>Results: </strong>The overall response rate was 48% (2025/4187). In four intraoperative clinical cases, anaesthesiologists administered on average 0.04 mg/kg MEQ less than nurse anaesthetists (95% CI: 0.03 to 0.04, p < 0.001), considered clinically relevant. Respondents with short working experience (< 10 years) administered 0.01 mg/kg MEQ less (95% CI: 0.00 to 0.02, p = 0.001). Respondents in the North Denmark Region administered 0.07 mg/kg MEQ more than the national average of 0.32 mg/kg MEQ (p < 0.001), considered clinically relevant. In postoperative clinical cases, significant dosing differences between short versus long working experience were not considered clinically relevant. Clinically relevant differences in dose-adjusting factors existed between professions (preoperative opioid use, age, body weight, alcohol use, chronic pain, and ASA classification) and regions (chronic pain, body weight, preoperative opioid use, ASA classification, sedation, BMI, and nausea).</p><p><strong>Conclusion: </strong>Clinical profession and regional background contribute to variation in opioid dosing strategies. Nurse anaesthetists and respondents from the North Denmark Region administered significantly and clinically relevant higher doses of opioids. Clinically relevant differences existed between professions and regions regarding opioid dose-adjusting factors.</p><p><strong>Editorial comment: </strong>This secondary analysis of survey results from Denmark regarding opioid choices and dosing preferences for post-surgical analgesia focused on professional categories and regions within Denmark. Some apparent dosing preference differences were described between professional groups and also between regions.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70222"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13044696/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147589161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic Accuracy of Arm Conicity to Detect Inaccurate Non-Invasive Blood Pressure Measurement in Obese Patients.","authors":"Victoria Eley, Anita Pelecanos, George Hopkins, Andre van Zundert, Michael Stowasser, Sean Gannon, Christine Woods, Adrian Chin","doi":"10.1111/aas.70236","DOIUrl":"10.1111/aas.70236","url":null,"abstract":"<p><p>Non-invasive blood pressure (NIBP) measurement can be challenging in patients with obesity. We aimed to determine if arm conicity, mid arm circumference or body mass index (BMI) could be used to predict pre-operative and intra-operative NIBP measurement error. Eligible patients had elective surgery and BMI ≥ 35 kg/m². Mid-arm circumference and arm slant angle (a measure of arm conicity) were measured according to standardised methods. Systolic (SBP) and diastolic (DBP) blood pressure were obtained using invasive (INV) and non-invasive methods at pre-induction (T0) and 20 min post-induction. NIBP accuracy was defined as ≤ 10 mmHg difference from invasive measurement. Post hoc analyses evaluated under and over-estimation. Receiver operating characteristic (ROC) curves were calculated. The 141 participants had a mean (SD) BMI of 46.9 (8.9) kg/m². There were 531 measurements at T0 and T20 with INV and NIBP available. Of 265 for SBP, 150 (56.7%) were inaccurate and of 266 for DBP, 113 (42.5%) were inaccurate. All ROC curves for right arm slant angle, right mid-arm circumference and BMI for SBP and DBP at T0 and T20 approached a 45° line. Area under ROC curves (AUROCs) ranged from 0.47 (0.36, 0.57) to 0.64 (0.54, 0.74), suggesting poor diagnostic performance. The best performer was right arm slant angle, with AUROCs 0.63 (0.51, 0.75) for DBP and 0.69 (0.59, 0.78) for SBP for underestimation at T0. Inaccurate measurements were common. Right arm conicity, mid-arm circumference and BMI were poor classifiers of NIBP measurement error at the pre-induction and intraoperative time points. EDITORIAL COMMENT: Accuracy of NIBP measurements in obese patients is uncertain. This clinical study compared routine oscillometric clinical blood pressure methods to a reference invasive blood pressure measure in an obese cohort. Significant disagreement between these is described, demonstrating reliability problems for some of the common arm oscillometric cuff implementations.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70236"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13080233/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147687819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Peri-Operative Glucocorticoids in Hip Fracture Patients on Post-Operative Outcomes: Systematic Review Protocol.","authors":"Charlotte Levy Hansen, Morten Vester-Andersen, Ann Merete Møller, Søren Overgaard, Nicolai Bang Foss, Daniel Hägi-Pedersen","doi":"10.1111/aas.70232","DOIUrl":"10.1111/aas.70232","url":null,"abstract":"<p><strong>Background: </strong>Hip fracture patients are often elderly and frail, with a high burden of comorbidity, placing them at substantial risk of post-operative delirium and other complications. Post-operative delirium is associated with prolonged recovery, functional decline, increased mortality and higher healthcare costs. Peri-operative glucocorticoids are widely used in peri-operative care and may modulate the inflammatory response associated with surgery, potentially reducing delirium and related adverse outcomes.</p><p><strong>Aim and hypothesis: </strong>This systematic review aims to evaluate the effects of peri-operative glucocorticoids on post-operative delirium in adults undergoing hip fracture surgery, as well as associated benefits and harms.</p><p><strong>Method: </strong>This protocol follows Cochrane methodology and PRISMA recommendations. The research question will be structured using the PICO framework. Randomised controlled trials and observational studies comparing peri-operative glucocorticoids with placebo or no peri-operative glucocorticoids will be included. The primary outcome is post-operative delirium incidence. Secondary outcomes include delirium severity, post-operative pain, morphine equivalents, patient satisfaction, length of stay, other adverse events as defined by author, and mortality. A comprehensive literature search will be conducted in multiple databases, supplemented by reference screening and searches for ongoing or unpublished studies. Meta-analysis will be performed where appropriate. Heterogeneity will be assessed, and subgroup or sensitivity analyses conducted as needed. Risk of bias and quality of evidence will be assessed using validated tools, and certainty of evidence will be evaluated using GRADE.</p><p><strong>Discussion: </strong>This review will synthesise current evidence on the efficacy and safety of peri-operative glucocorticoids in hip fracture surgery, with a particular focus on post-operative delirium. The findings may inform clinical practise and guide future research in this vulnerable patient population.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70232"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13044695/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147589169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early Prediction of Neurological Outcome After Cardiac Arrest-Rationale and Design of the Prospective International Observational EARLY-NEURO, a STEPCARE Substudy.","authors":"Marion Moseby-Knappe, Erik Westhall, Marjolein Admiraal, Margareta Lang, Helena Levin, Johanna Hästbacka, Marjaana Tiainen, Markus Skrifvars, Gisela Lilja, Janus C Jacobsen, Alice Lagebrant, Matt Wise, Matti Reinikainen, Paul Young, Manoj Saxena, Simon Schmidbauer, Naomi Hammond, Frances Bass, Ameldina Ceric, Caroline Kamp, Christina Sillassen, Christoph Leithner, Pascal Stammet, Matthias P Hilty, Pedro D Wendel-Garcia, Georg Royl, Tobias Graf, Matt Thomas, Katie Sweet, Stepani Bendel, Joonas Tirkkonen, Annerose Mengel, Maria-Ioanna Stefanou, Luis Georg Romundstad, Philipp Seidel, Jessica Kåhlin, Jonathan Grip, Jonna Heinonen, Rakesh H Jadav, Jens Nee, Daniela Nowak, Matthias Hänggi, Johan Undén, Anna Lybeck, Joachim Düring, Martin Kenda, Jesper Johnsson, Niklas Nielsen, Tobias Cronberg","doi":"10.1111/aas.70239","DOIUrl":"10.1111/aas.70239","url":null,"abstract":"<p><strong>Background: </strong>Guidelines discourage prediction of neurological outcome in comatose patients within the first 72 h after cardiac arrest. Increasing evidence suggests that patients with the most severe brain injury and those with no or minimal brain injury may be identified before 72 h using novel methods. We present a protocol for the EARLY-NEURO study, which aims to evaluate whether good and poor outcomes can be reliably predicted already from 24 h after cardiac arrest using the most commonly available methods.</p><p><strong>Methods: </strong>Protocol for a prospective international multicenter substudy within the Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial where adults post-arrest are randomized to minimal or deep sedation, fever treatment with or without a temperature management device and to two different targets of mean arterial blood pressure. Patients sedated or still unconscious at 24 h are examined with head computed tomography (CT) and electroencephalogram (EEG). Blood samples are collected at 24 h after randomization, and stored for analysis of the brain injury marker neurofilament light. CT and EEG examinations will be centrally evaluated for signs of a likely poor or good outcome applying standardized criteria by raters blinded to treatment allocations and patient outcomes. Intensive care treatment, neurological prognostication, and criteria for withdrawal of care will be according to the STEPCARE protocol. Timepoint and reasons for withdrawal of life-sustaining therapy (WLST) will be recorded. WLST prior to 72 h after randomization based on a presumed futile neurological prognosis is strongly discouraged. Primary outcome will be good or poor functional outcome, assessed by the modified Rankin Scale (dichotomized as 0-3 versus 4-6) at 6 months. Results will be reported in accordance with the Standards for Reporting Diagnostic Accuracy (STARD).</p><p><strong>Conclusions: </strong>Earlier prognostication aims to balance the avoidance of premature treatment withdrawal in patients with favorable potential against the prevention of unnecessary intervention in patients with a definitely poor prognosis.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70239"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13088753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147697498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Continuous Versus Intermittent Glucose Monitoring in Intensive Care Unit Patients: A Systematic Review With Meta-Analysis.","authors":"Christian Lange Gantzel, Milda Grigonyte-Daraskeviciene, Mathias Maagaard, Peter Lommer Kristensen, Ulrik Pedersen-Bjergaard, Mikkel Thor Olsen, Kirsten Nørgaard, Anders Perner, Johan Mårtensson, Morten Hylander Møller, Morten Heiberg Bestle","doi":"10.1111/aas.70226","DOIUrl":"10.1111/aas.70226","url":null,"abstract":"<p><strong>Introduction: </strong>Glucose management in intensive care unit (ICU) patients often relies on point of care (POC) blood glucose measurements. An increasing number of randomized clinical trials (RCTs) have investigated continuous glucose monitoring (CGM) compared to POC, but effects on patient-important outcomes are uncertain.</p><p><strong>Methods: </strong>We systematically searched PubMed, Embase, CENTRAL, CINAHL and Web of Science. All reporting was done according to the PRISMA guideline. We included RCTs in ICU patients comparing the effects of CGM versus POC on glycemic and clinical outcomes. We performed meta-analyses, Trial Sequential Analysis, and assessed the certainty of the evidence using GRADE.</p><p><strong>Results: </strong>We identified 1271 records and included 18 RCTs comparing CGM versus POC with a total of 2027 participants; 15 trials with 1600 participants reported on mortality (relative risk 0.61, 95% CI 0.35-1.04; very low certainty evidence) and 14 trials with 1515 participants on hypoglycemia (relative risk 0.44, 95% CI 0.23 to 0.82; very low certainty evidence). None of our remaining secondary outcomes were reported in the trials. We identified potential benefits of CGM versus POC on glycemic process outcomes; however, we did not evaluate certainty of evidence.</p><p><strong>Conclusions: </strong>CGM used for glucose management in ICU patients may reduce mortality and hypoglycemia, but the evidence is very uncertain. Sufficiently powered trials at low risk of bias are needed to confirm potential beneficial effects.</p><p><strong>Editorial comment: </strong>This meta-analysis reports the available literature on continuous versus intermittent monitoring of blood glucose in critically ill patients. The authors found that the available evidence was very uncertain, although continuous monitoring might improve outcomes. It is likely that this is partially due to lack of standardization of measurements and different management strategies. It is possible that the question is best answered with a larger trial with a well-defined treatment protocol.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70226"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13035928/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147580260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse Effects Associated With Spinal Versus General Anaesthesia for Hip and Knee Arthroplasties: Protocol for a Systematic Review.","authors":"Anne Sofie Nautrup Therkelsen, Hans Bredgaard Christensen, Anne-Lene Kjældgaard, Camilla Godthaab, Christina Dam Bjerregaard Sillassen, Troels Haxholdt Lunn, Daniel Hägi-Pedersen, Claus Varnum, Martin Lindberg-Larsen, Kasper Højgaard Thybo, Janus Christian Jakobsen, Ole Mathiesen","doi":"10.1111/aas.70231","DOIUrl":"10.1111/aas.70231","url":null,"abstract":"<p><strong>Background: </strong>Spinal and general anaesthesia are the most common anaesthetic methods for hip and knee arthroplasties. Differences in their effects on short- and long-term postoperative outcomes, including mortality morbidity, and adverse events, remain uncertain. Identifying the anesthetic method that provides the best recovery could help optimise patient care. Previous reviews have reported conflicting results and have methodological limitations, highlighting the need for an updated systematic review.</p><p><strong>Methods: </strong>This protocol describes a Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) compliant systematic review and meta-analysis of randomised clinical trials, incorporating Trial sequential analysis. The review aims to evaluate the beneficial and harmful effects of spinal versus general anaesthesia in adult patients undergoing hip or knee arthroplasty. To identify relevant trials, we will search major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries and include all trials directly comparing spinal versus general anaesthesia. Two review authors will independently screen the literature, extract data and conduct risk of bias assessment (Cochrane Risk of Bias tool-version 2 (RoB-2)). The primary outcome will be the proportion of participants with one or more serious adverse events. Secondary outcomes will be pain, postoperative opioid consumption, time to first mobilisation, hospital length of stay, non-serious adverse events, and quality of recovery. The certainty of evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and presented in a 'Summary of Findings' table.</p><p><strong>Discussion: </strong>To guide clinicians in choosing between spinal and general anaesthesia for hip and knee arthroplasties, a systematic review of the existing evidence is needed. This review will support clinicians and patients in weighing the benefits against the harms of the two anaesthetic methods and in making evidence-based, informed decisions.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70231"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13035446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147580278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Key Features of Contemporary Pilot and Feasibility Trials: Protocol for a Methodological Study.","authors":"Aske Tøgern, Morten H Møller, Anders Perner, Maj-Brit N Kjær, Ruben J Eck, Carl T Anthon, Jehad A Barakji, Anders Granholm","doi":"10.1111/aas.70228","DOIUrl":"10.1111/aas.70228","url":null,"abstract":"<p><strong>Background: </strong>Randomised clinical trials (RCTs) are costly undertakings requiring careful design, planning and conduct. Failure to achieve timely participant recruitment, separation between intervention groups and adequate follow-up contributes to waste in research. Pilot RCTs offer researchers the opportunity to examine whether a definitive trial may work as intended, for example, assessing whether the targeted sample size can be recruited, whether protocol adherence and between-group separation are achievable and whether outcome data can be collected. To maximise their value, more attention to the design, conduct and reporting of pilot RCTs is likely required. Here, we aim to describe and characterise feasibility assessment methodology in a cohort of contemporary pilot RCTs in hospitalised patients.</p><p><strong>Methods: </strong>In this methodological study, we will describe key features of contemporary pilot RCTs in hospitalised patients across medical and surgical specialties. We will search for pilot/feasibility RCTs published within the last half calendar year, with the aim of including at least 100 RCTs assessing feasibility. If necessary to achieve the minimum sample, the search will be expanded to a maximum of 5 years. We will extract data on key trial characteristics (including area of care and type of intervention and comparator), whether feasibility was assessed and feasibility assessment methodology (feasibility areas assessed, conduct as stand-alone pilot, use of pre-defined outcomes and pre-specified criteria for progression to definitive RCT, adequacy of sample size justification, plans for definitive RCT, assessment of clinical outcomes and whether a definitive trial was deemed feasible). Findings will be summarised using descriptive statistics for all trials and stratified by intervention type, area of care and comparator type.</p><p><strong>Conclusions: </strong>The outlined methodological study will provide data on key features of contemporary pilot RCTs in hospitalised patients, including the feasibility assessment methodologies employed. This may improve design, conduct and reporting of future pilot RCTs, ultimately increasing their value and reducing research waste.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70228"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13021571/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147519857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drainage of Pleural Effusion in the Intensive Care Unit (DOPE-ICU) Feasibility Trial-Protocol and Statistical Analysis Plan.","authors":"Marie Schjødt Worm, Morten Hylander Møller, Niels Henrik Bruun, Anne Craveiro Brøchner, Morten Heiberg Bestle, Bodil Steen Rasmussen, Olav Lilleholt Schjørring","doi":"10.1111/aas.70233","DOIUrl":"10.1111/aas.70233","url":null,"abstract":"<p><p>Pleural effusions are common in adult intensive care unit (ICU) patients with respiratory failure. Ultrasonography-guided therapeutic pleural drainage is widely used and associated with improved oxygenation and ventilatory parameters, but no randomised clinical trial data exist. This paper outlines the protocol and detailed statistical analysis plan for the Drainage Of Pleural Effusions in the ICU (DOPE-ICU) feasibility trial. This is an investigator-initiated, pragmatic, multicentre, open-label, randomised, parallel-group feasibility trial. Adults acutely admitted to the ICU with pleural effusion ≥ 2 cm and respiratory failure will be screened for inclusion. We will exclude patients with existing pleural or mediastinal drain, suspected or confirmed haemothorax, pneumothorax, empyema or pleural malignancy, coagulation deficiency or antithrombotic therapy incompatible with drainage, clinical indication for therapeutic pleural drainage and predefined severe hypoxaemic or hypercapnic respiratory failure, expected ICU stay < 24 h, pregnancy, imminent withdrawal of active therapy, or patients previously randomised in the trial. A total of 88 eligible patients will be allocated 1:1 to ultrasonography-guided therapeutic pleural drainage with small-bore catheter, with repeated drainage of repeated pleural effusions during ICU stay including readmissions within 90 days versus no therapeutic pleural drainage during ICU stay within 90 days unless pre-specified escape criteria apply. The primary outcome is a feasibility outcome assessing group separation, i.e., proportion of patients receiving pleural drainage in ICU within 90 days. Secondary clinical outcomes include all-cause 90-day mortality, number of patients with one or more serious adverse events within 90 days, and absolute number of days alive without life support and out of hospital, respectively, in 90 days. Additional secondary feasibility and process outcomes will also be investigated. Data will be compared in the intension-to-treat population using generalised linear models adjusted for the stratification variable trial site. ClinicalTrials.gov identifier: NCT06709456. The DOPE-ICU feasibility trial will assess whether randomised allocation to ultrasonography-guided therapeutic pleural drainage or not in adult ICU patients with respiratory failure and pleural effusion is feasible. This will inform the design of a future large randomised clinical trial evaluating the clinical effects and safety of pleural drainage in this population.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70233"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13062606/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147637645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risks of Serious Adverse Events Associated With Non-Steroidal Anti-Inflammatory Drugs in Orthopaedic Surgery. A Systematic Review With Meta-Analysis and Trial Sequential Analysis.","authors":"Shaheer Bukhari, Morten F Leth, Christina C W Laursen, Mia E Larsen, Anders S Tornøe, Nikolaj K Schou, Marie Glad, Amanda de la Fuente, Janus C Jakobsen, Mathias Maagard, Ole Mathiesen","doi":"10.1111/aas.70237","DOIUrl":"10.1111/aas.70237","url":null,"abstract":"<p><strong>Background: </strong>Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for perioperative analgesic treatment. However, NSAID treatment may be associated with increased risk of adverse events. We investigated the risks of serious adverse events with perioperative NSAID treatment in patients undergoing orthopaedic surgery.</p><p><strong>Methods: </strong>We conducted a systematic review (PROSPERO: CRD42022342003) of randomised clinical trials assessing the harmful effects associated with the use of NSAIDs versus placebo, usual care, or no intervention in patients undergoing orthopaedic surgery. The primary outcome was the incidence of serious adverse events. We systematically searched for eligible trials up to October 13, 2025. We performed risk of bias assessments to account for systematic errors, Trial Sequential Analysis to account for the risks of random errors, performed meta-analyses using R, and used The Grading of Recommendations Assessment, Development and Evaluation framework to assess the certainty of the evidence.</p><p><strong>Results: </strong>We included 38 trials enrolling 6593 patients for our primary outcome. Most trials were of high risk of bias. Meta-analysis showed no statistically significant difference between NSAID and placebo for risk of serious adverse events, RR 0.83; 95% CI, 0.61 to 1.14; p = 0.26; very low certainty of evidence. Post hoc beta-binomial regression sensitivity analyses, including trials with zero events, indicated no difference in risks of serious adverse events between NSAID and placebo (OR 0.89; 95% CI, 0.76 to 1.06; p = 0.19). Trial Sequential Analysis showed that insufficient information was obtained to confirm or reject a relative risk change of 25%.</p><p><strong>Conclusion: </strong>In adult patients undergoing orthopaedic surgery, we found no evidence of a difference between NSAID and placebo regarding risk of serious adverse events. However, the available data were insufficient to draw firm conclusions, and the certainty of evidence was generally very low.</p><p><strong>Editorial comment: </strong>This systematic review with meta-analysis was aimed at assessing non-steroidal anti-inflammatory drug treatments for reported serious adverse effects in post-operative analgesia trials in orthopedic surgical cohorts. These drugs are routinely part of modern multimodal or pre-emptive analgesia treatment routines. The published evidence was generelly assessed to have a high risk of bias or low certainty for this specific question. No clear difference in reported event risk between this type of drug and placebo was found, though it is not clear that this is conclusive.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"70 5","pages":"e70237"},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13084487/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147687289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}