Acta Anaesthesiologica Scandinavica最新文献

{"title":"Intraoperative Clonidine in Spine Surgery: A Randomised Controlled Trial.","authors":"Stine Birkebæk, Niels Juul, Mikkel Mylius Rasmussen, Peter Gaarsdal Uhrbrand, Lone Nikolajsen","doi":"10.1111/aas.70048","DOIUrl":"10.1111/aas.70048","url":null,"abstract":"<p><p>Patients undergoing spine surgery often experience post-operative pain. In this context, clonidine, an alpha-2 agonist, may be relevant due to its analgesic properties. We conducted a randomised, double-blinded, placebo-controlled trial to evaluate the effect of a single dose of intraoperative intravenous clonidine on post-operative opioid consumption, pain intensity and side effects. Patients undergoing spine surgery at Aarhus University Hospital, Denmark, were randomised to receive intraoperative clonidine (3 μg/kg) or placebo. The primary outcome was opioid consumption within the first 3 h after surgery. Secondary outcomes included opioid consumption within the first 6 h, pain intensity at rest and during coughing, post-operative nausea and vomiting (PONV), and sedation in the post-anaesthesia care unit (PACU). Additional outcomes included time to discharge from the PACU, length of hospital stay and daily opioid consumption after 1 month. Data from 120 patients (49 females, 71 males, mean age 65 ± 14 years) were available for analysis; 61 received clonidine and 59 received placebo. Post-operative intravenous morphine equivalents within 3 h were similar in the clonidine group 5 mg (0-15) and the placebo group 10 mg (0-15) (p = 0.58). Pain intensity at rest was 4 (0-5.5) in the clonidine group and 3 (0-5) in the placebo group upon arrival at the PACU (p = 0.20). No differences were observed between the clonidine and placebo groups regarding any secondary outcomes, except for hypotension, which was more frequent in the clonidine group (24 vs. 13 patients). A single dose of intraoperative clonidine did not reduce post-operative opioid consumption or pain intensity in patients undergoing spine surgery.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 6","pages":"e70048"},"PeriodicalIF":1.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967690","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":"Laryngotracheal Pathologies and Symptoms Associated to Airway Management of Critically Ill COVID-19 Patients at One-Year Follow Up: An Observational Study.","authors":"Svenberg Lind Clara, Karlsson Agneta, Marsk Elin, Kåhlin Jessica, Von Beckerath Mathias, Mårtensson Johan, Wanecek Michael, Vlastos Andrea, Hynning Boel, Aspelund Liljequist Amalia, Söderin Louise, Wales Jeremy","doi":"10.1111/aas.70074","DOIUrl":"10.1111/aas.70074","url":null,"abstract":"<p><strong>Background: </strong>The European laryngological society predicted an increased incidence of laryngotracheal complications as a result of the COVID-19 pandemic. During the first pandemic wave in the Stockholm region, 31% of critically ill COVID-19 patients were tracheotomized by an open surgical (OST) or a percutaneous tracheotomy (PCT). The aim of this study was to investigate the incidence of visible laryngotracheal pathologies in tracheotomized and long-term intubated COVID-19 survivors ≥ 12 months after initial intubation, to examine whether these pathologies were symptomatic and to assess possible associated factors.</p><p><strong>Methods: </strong>Study participants underwent laryngotracheoscopy under local anaesthesia, and tracheostomy skin and soft tissue scars were photo documented. Patient-reported outcome measures - the Voice Handicap Index-10 (VHI-10), the Eating Assessment Tool-10 (EAT-10) and the Dyspnea Index (DI), and demographics were retrospectively extracted from patient medical records.</p><p><strong>Results: </strong>Of 73 included study participants (40 OST, 24 PCT and 9 long-term intubated), 58% had visible laryngotracheal pathologies. Tracheostomy tube size and the number of days with tracheostomy were associated with skin and soft tissue pathology and tracheal pathology (p < 0.05). The results of the VHI-10 and EAT-10 were congruent with both laryngeal and skin and soft tissue pathologies. Participants with the highest DI scores, indicating breathing difficulties, had both laryngeal and tracheal pathologies followed by tracheal pathology alone.</p><p><strong>Conclusions: </strong>A high incidence of visible laryngotracheal pathologies, two airway management-related factors, and symptom-pathology associations for VHI-10 and EAT-10 scores were found in a cohort of COVID-19 survivors ≥ 12 months after critical care.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 6","pages":"e70074"},"PeriodicalIF":1.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12177439/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144324134","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 Opioids on Pupil Initial Diameter and Pupillary Dilation Velocity in ICU Patients.","authors":"Valdemar Oskar Ingemann Sørensen, Stine Uhrenholt, Jannik Stokholm, Thomas Christensen, Morten Heiberg Bestle","doi":"10.1111/aas.70080","DOIUrl":"10.1111/aas.70080","url":null,"abstract":"<p><strong>Background: </strong>Pupillary light reflex assessment is a promising modality for assessing autonomic nervous system status, given that it is fast, noninvasive, and provides quantitative results. Opioid therapy influences the pupil and is frequently used in the intensive care unit (ICU). We investigated the effect of opioids on pupillary size and dilation velocity in the pupillary light reflex in critically ill patients.</p><p><strong>Methods: </strong>This is a sub-study on 55 patients from a prospective observational study acutely admitted to an ICU. All patients had daily blood samples and pupillary light reflex measurements. Blood samples were analyzed for opioids using mass spectrometry. Linear mixed models were used to estimate the possible association for each detected opioid to pupillary size and dilation velocity in the pupillary light reflex.</p><p><strong>Results: </strong>The pupil size before a light stimulus was closely associated to the dilation velocity after the light stimulus. The increase in the dilation velocity was 0.2 mm/s per 1 mm increase in pupil diameter before the light stimulus, 95% confidence interval [0.2-0.3], p < 0.001. Presence of fentanyl was associated with a smaller pupil size and a slower pupillary dilation velocity.</p><p><strong>Conclusions: </strong>The presence of fentanyl in blood samples from a mixed ICU population is associated with a slower pupillary dilation velocity in a concentration-dependent matter.</p><p><strong>Editorial comment: </strong>This study assesses the relation of observed opioid levels and light reflex pupillary size speed of change in an ICU cohort where there can be multiple classes of drugs present which influence autonomic nerve system function. Findings for different opioids, though most specifically fentanyl, show that opioid plasma concentrations have clear association with slower pupillary dilation velocity with light reflex response.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 6","pages":"e70080"},"PeriodicalIF":1.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12185176/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144473715","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":"Plasma Trough Concentrations of Beta-Lactam Antibiotics in the Early Phase of Septic Shock.","authors":"Malin Hägglund, Magnus Brink, Ulrika Snygg Martin, Daniel Bremell, Carl Johan Svensson","doi":"10.1111/aas.70050","DOIUrl":"10.1111/aas.70050","url":null,"abstract":"<p><strong>Introduction: </strong>Septic shock necessitates timely antibiotic therapy, often with broad-spectrum beta-lactam antibiotics (ß-LA). To our knowledge, no previous study has examined antibiotic concentrations repeatedly during the initial phase of treatment. This observational study aimed to assess early-phase plasma concentrations of ß-LA in patients with septic shock.</p><p><strong>Method: </strong>Prospective observational study of patients with septic shock, according to the SEPSIS-3 criteria, who received cefotaxime, piperacillin/tazobactam, or meropenem in accordance with Swedish practice. Demographic and clinical data were recorded for each patient. Consecutive blood samples were obtained during the first 24 h of treatment, and total antibiotic concentrations were measured using liquid chromatography mass spectrometry. Target concentrations were defined as 100% of the time that free (unbound) antibiotic concentrations remained above the minimal inhibitory concentration (fT > MIC).</p><p><strong>Results: </strong>Twenty-two patients were included, 15 (68%) were male and the median age was 65.5 years (IQR 46.3-65.5). In-hospital mortality was 7/22 (32%). Antibiotic exposure exceeding 100% fT > MIC was achieved in 16 (73%) of the patients. Four patients did not receive the recommended additional dose between the first and second doses of antibiotics; two of them still achieved 100% fT > MIC, whereas the other two attained 66% and 33% fT > MIC, respectively. Among the patients who received the additional dose, four did not achieve 100% fT > MIC. No relationship between mortality and fT > MIC was observed. Significant associations with achieving 100% fT > MIC were observed for older age (p = 0.045) and illness severity (SAPS3, p = 0.025).</p><p><strong>Conclusion: </strong>Our findings demonstrate considerable variability in antibiotic exposure during the initial 24 h of septic shock treatment, highlighting a critical gap in understanding the clinical relevance of sub-optimal serum antibiotic concentrations and their potential impact on patient outcomes.</p><p><strong>Editorial comment: </strong>Therapeutic drug monitoring of antimicrobials is increasingly being used in research and clinical practice.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 6","pages":"e70050"},"PeriodicalIF":1.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12047412/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143954950","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":"Ultrasound-Guided Nerve Blocks Improve Success Rate of Closed Reduction of Colles' Fractures: A Randomised Controlled Trial.","authors":"Anette B Christensen, Christine IIkjær, Torben K Laustrup, Esben Sejer, Camilla Rønnøw, Kaj V Døssing, Troels B Jensen, Jacob K Andersen, Christoffer G Sølling","doi":"10.1111/aas.70063","DOIUrl":"10.1111/aas.70063","url":null,"abstract":"<p><strong>Background: </strong>The initial treatment for distal forearm fractures, including Colles' fractures, involves closed reduction, for which effective pain management is essential. In Colles' fractures, achieving a satisfactory closed reduction may eliminate the need for surgical intervention. While ultrasound-guided nerve blocks are effective, hematoma blocks (HB) are often favored due to their feasibility in the emergency care setting. Further research comparing treatment outcomes is warranted.</p><p><strong>Methods: </strong>In a multicentre randomised controlled trial, adults with distal forearm fractures were assigned to either ultrasound-guided blocks of the radial and median nerves (US) or HB for closed fracture reduction. The primary endpoint was satisfactory fracture reduction. Secondary endpoints were secondary fracture dislocation, self-reported pain, and time spent in the emergency department.</p><p><strong>Results: </strong>Among 238 patients with Colles' fracture, 117 received US and 121 received HB. Satisfactory fracture reduction was achieved in 73 (62%) and 49 (40%) patients, respectively (p = 0.01). Surgical correction was conducted in 61 (52%) patients in the US group, contrasting 80 (66%) patients in the HB group (p = 0.03). During the fracture reduction, no difference in self-reported pain was observed (p = 0.21) for patients with distal forearm fractures (n = 247). The median time from block application to fracture reduction was 45 min in the US group and 25 min in the HB group (p < 0.01).</p><p><strong>Conclusion: </strong>Ultrasound-guided median and radial nerve blocks had a higher success rate for Colles' fracture reduction than the hematoma block group. The influence of anesthetic techniques on the eventual need for surgery requires further investigation.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 6","pages":"e70063"},"PeriodicalIF":1.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12178230/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144324135","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":"Epidural anesthesia and analgesia in neonates and infants: Protocol for a scoping review.","authors":"Line Gry Larsen, Tom Geidsing Hansen","doi":"10.1111/aas.70029","DOIUrl":"https://doi.org/10.1111/aas.70029","url":null,"abstract":"<p><strong>Background: </strong>Surgery and anesthesia in neonates and infants are performed only when necessary due to their immature physiological systems and limited cardiorespiratory reserves, rendering them particularly susceptible to complications. Effective pain management in the context of major surgical procedures presents a considerable challenge. Untreated pain activates cellular and humoral pathways that are detrimental to recovery. Although opioids are effective analgesics, their use is associated with hypoventilation and may exacerbate the physiological apnea commonly observed in newborns. This can extend the requirement for positive pressure ventilation, increasing the risks of both immediate and long-term adverse outcomes. Epidural anesthesia and analgesia offer a promising alternative by providing effective pain relief while reducing opioid consumption, thus minimizing respiratory impairment and promoting more rapid recovery. This scoping review aims to map existing knowledge, to shed light on knowledge gaps, and lay the groundwork for further research.</p><p><strong>Methods: </strong>This review will follow the JBI methodology and adhere to the PRISMA guidelines for Scoping Reviews. A comprehensive search will be conducted across peer-reviewed databases, published literature, online resources, ongoing studies, and gray literature to identify all available evidence on epidural anesthesia and analgesia in thoracic and abdominal surgeries in neonates and infants.</p><p><strong>Results: </strong>The findings from the included studies will be synthesized narratively and presented with tables and figures to ensure a clear and structured overview.</p><p><strong>Conclusion: </strong>This scoping review aims to summarize the current evidence on epidural anesthesia and analgesia in neonates and infants. It will highlight well-researched areas, identify gaps in the literature, and outline existing knowledge and unmet research needs in this field.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 5","pages":"e70029"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12009654/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958881","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":"Dysphagia in the intensive care unit-Screening requirements.","authors":"Joerg C Schefold, Daniela Bertschi, Philipp Venetz, Bodil Steen Rasmussen","doi":"10.1111/aas.70035","DOIUrl":"https://doi.org/10.1111/aas.70035","url":null,"abstract":"","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 5","pages":"e70035"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12013242/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143963821","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":"Oxygen Saturation in Relation to Flying Altitude. A Scoping Review Protocol.","authors":"Joachim Kvernberg, Finn Lund Henriksen, Kasper Glerup Lauridsen, Marius Rehn, Peter Martin Hansen","doi":"10.1111/aas.70041","DOIUrl":"https://doi.org/10.1111/aas.70041","url":null,"abstract":"<p><strong>Background: </strong>During air travel, the decrease in air pressure leads to a decrease in oxygen partial pressure causing oxygen desaturation. Every year, several commercial aircraft need to divert and perform unscheduled landings due to hypoxic symptoms or medical emergencies. How individuals are affected depends on their physical and medical conditions, as well as the cabin pressure of the aircraft. The phenomenon is of particular concern for individuals with pre-existing medical conditions, as it may lead to hypoxic symptoms and necessitate unscheduled landings in some cases. The investigators aim to investigate the existing literature to explore how the impact of reduced oxygen partial pressure affects the oxygen saturation as a result of a decrease in cabin pressure due to aircraft altitude, and to assess the frequency of hypoxic symptoms reported during air travel. The purpose of the scoping review is to investigate the relationship between altitude, cabin pressure, and patient oxygenation during air travel. Further, the investigators will report the frequency of the reporting of hypoxic symptoms in the studies conducted.</p><p><strong>Methods and analysis: </strong>This scoping review will be conducted in accordance with the Cochrane Handbook and Joanna Briggs Institute Manual for Scoping Reviews. The review question will be formulated using the Population, Intervention, Comparator, Outcome, Study Design, Timeframe (PICOST) framework. Every study design is eligible, apart from reviews, meta-analyses, comments/letters without original data, case reports with less than five cases, animal studies, and in vitro studies. The investigators will include all articles in English or Scandinavian. The investigators will base their conclusions on the findings of the review.</p><p><strong>Ethics and dissemination: </strong>According to Danish law, scoping reviews are exempt from ethics committee approval. The investigators will publish results from the scoping review in a peer-reviewed journal and present the results at scientific conferences.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 5","pages":"e70041"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12014421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958758","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":"Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial.","authors":"A Ceric, J Dankiewicz, J Hästbacka, P Young, V H Niemelä, F Bass, M B Skrifvars, N Hammond, M Saxena, H Levin, G Lilja, M Moseby-Knappe, M Tiainen, M Reinikainen, J Holgersson, C B Kamp, M P Wise, P J McGuigan, J White, K Sweet, T R Keeble, G Glover, P Hopkins, C Remmington, J M Cole, N Gorgoraptis, D G Pogson, P Jackson, J Düring, A Lybeck, J Johnsson, J Unden, A Lundin, J Kåhlin, J Grip, E M Lotman, L Romundstad, P Seidel, P Stammet, T Graf, A Mengel, C Leithner, J Nee, P Druwé, K Ameloot, A Nichol, M Haenggi, M P Hilty, M Iten, C Schrag, M Nafi, M Joannidis, C Robba, T Pellis, J Belohlavek, D Rob, Y M Arabi, S Buabbas, C Yew Woon, A Aneman, A Stewart, M Reade, C Delcourt, A Delaney, M Ramanan, B Venkatesh, L Navarra, B Crichton, A Williams, D Knight, J Tirkkonen, T Oksanen, T Kaakinen, S Bendel, H Friberg, T Cronberg, J C Jakobsen, N Nielsen","doi":"10.1111/aas.70022","DOIUrl":"10.1111/aas.70022","url":null,"abstract":"<p><strong>Background: </strong>Sedation is often provided to resuscitated out-of-hospital cardiac arrest (OHCA) patients to tolerate post-cardiac arrest care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after cardiac arrest is limited. The aim of this trial is to investigate the effects of continuous deep sedation compared to minimal sedation on patient-important outcomes in resuscitated OHCA patients in a large clinical trial.</p><p><strong>Methods: </strong>The SED-CARE trial is part of the 2 × 2 × 2 factorial Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, a randomized international, multicentre, parallel-group, investigator-initiated, superiority trial with three simultaneous intervention arms. In the SED-CARE trial, adults with sustained return of spontaneous circulation (ROSC) who are comatose following resuscitation from OHCA will be randomized within 4 hours to continuous deep sedation (Richmond agitation and sedation scale (RASS) -4/-5) (intervention) or minimal sedation (RASS 0 to -2) (comparator), for 36 h after ROSC. The primary outcome will be all-cause mortality at 6 months after randomization. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to the allocation group. To detect an absolute risk reduction of 5.6% with an alpha of 0.05, 90% power, 3500 participants will be enrolled. The secondary outcomes will be the proportion of participants with poor functional outcomes 6 months after randomization, serious adverse events in the intensive care unit, and patient-reported overall health status 6 months after randomization.</p><p><strong>Conclusion: </strong>The SED-CARE trial will investigate if continuous deep sedation (RASS -4/-5) for 36 h confers a mortality benefit compared to minimal sedation (RASS 0 to -2) after cardiac arrest.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 5","pages":"e70022"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11967157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143770937","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":"Sedation, temperature and pressure after cardiac arrest and resuscitation-The STEPCARE trial: A statistical analysis plan.","authors":"C B Kamp, J Dankiewicz, M Harboe Olsen, J Holgersson, M Saxena, P Young, V H Niemelä, J Hästbacka, H Levin, G Lilja, M Moseby-Knappe, M Tiainen, M Reinikainen, A Ceric, J Johnsson, J Undén, J Düring, A Lybeck, D Rodriguez-Santos, A Lundin, J Kåhlin, J Grip, E Lotman, L Romundstad, P Seidel, P Stammet, T Graf, A Mengel, C Leithner, J Nee, P Drúwe, K Ameloot, M P Wise, P J McGuigan, A Ratcliffe, J Cole, J White, N Pareek, G Glover, R Handslip, A Proudfoot, M Thomas, D Pogson, T R Keeble, A Nichol, M Haenggi, M P Hilty, M Iten, C Schrag, M Nafi, M Joannidis, C Robba, T Pellis, J Belohlavek, O Smid, D Rob, Y Arabi, S Buabbas, C Yew Woon, Q Li, M Reade, A Delaney, B Venkatesh, N Hammond, F Bass, A Aneman, A Stewart, L Navarra, B Crichton, D Knight, A Williams, J Tirkkonen, T Oksanen, T Kaakinen, S Bendel, H Friberg, T Cronberg, M B Skrifvars, N Nielsen, J C Jakobsen","doi":"10.1111/aas.70033","DOIUrl":"https://doi.org/10.1111/aas.70033","url":null,"abstract":"<p><strong>Background: </strong>Basic management for patients who have suffered a cardiac arrest and are admitted to an intensive care unit (ICU) after resuscitation includes setting targets for blood pressure and managing sedation and temperature. However, optimal targets and management are unknown.</p><p><strong>Methods: </strong>The STEPCARE (Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation) trial is a multicenter, parallel-group, randomized, factorial, superiority trial in which sedation, temperature, and blood pressure strategies will be studied in three separate comparisons (SED-CARE, TEMP-CARE, and MAP-CARE). The trial population will be adults admitted to intensive care who are comatose after resuscitation from out-of-hospital cardiac arrest. The primary outcome will be all-cause mortality, and the secondary outcomes will be poor functional outcome (modified Rankin Scale 4-6), Health-Related Quality of Life using EQ-VAS, and specific serious adverse events in the intensive care unit predefined for each trial. All outcomes will be assessed at 6 months after randomization. The prognosticators, outcome assessors, statisticians, data managers, steering group, and manuscript writers will be blinded to treatment allocation. This statistical analysis plan includes a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Analyses will be conducted according to the intention-to-treat principle, that is, all randomized participants with available data will be included. The analyses will be performed independently by two statisticians following the present plan.</p><p><strong>Conclusion: </strong>This statistical analysis plan describes the statistical analyses for the STEPCARE trial in detail. The aim of this predefined statistical analysis plan is to minimize the risk of analysis bias.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":"69 5","pages":"e70033"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11985327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959275","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}