Benjamin Skov Kaas-Hansen, Maj-Brit Nørregaard Kjaer, Morten Hylander Møller, Aksel Karl Georg Jensen, Mia Esta Larsen, Brian H Cuthbertson, Anders Perner, Anders Granholm
{"title":"Health-related quality of life trajectories in critical illness: Protocol for a Monte Carlo simulation study.","authors":"Benjamin Skov Kaas-Hansen, Maj-Brit Nørregaard Kjaer, Morten Hylander Møller, Aksel Karl Georg Jensen, Mia Esta Larsen, Brian H Cuthbertson, Anders Perner, Anders Granholm","doi":"10.1111/aas.14324","DOIUrl":"10.1111/aas.14324","url":null,"abstract":"<p><strong>Background: </strong>Health-related quality of life (HRQoL) is a patient-centred outcome increasingly used as a secondary outcome in critical care research. It may cover several important dimensions of clinical status in intensive care unit (ICU) patients that arguably elude other more easily quantified outcomes such as mortality. Poor associations with harder outcomes, conflicting data on HRQoL in critically ill compared to the background population, and paradoxical effects on HRQoL and mortality complicate the current operationalisation in critical care trials. This protocol outlines a simulation study that will gauge if the areas under the HRQoL trajectories could be a viable alternative.</p><p><strong>Methods: </strong>We will gauge the behaviour of the proposed HRQoL operationalisation through Monte Carlo simulations, under clinical scenarios that reflect a broad critical care population eligible for inclusion in a large pragmatic trial. We will simulate 15,360 clinical scenarios based on a full factorial design with the following seven simulation parameters: number of patients per arm, relative mortality reduction in the interventional arm, acceleration of HRQoL improvement in the interventional arm, the relative improvement in final HRQoL in the interventional arm, dampening effect of mortality on HRQoL values at discharge from the ICU, proportion of so-called mortality benefiters in the interventional arm and mortality trajectory shape. For each clinical scenario, we will simulate 100,000 two-arm trials with 1:1 randomisation. HRQoL will be sampled fortnightly after ICU discharge. Outcomes will include HRQoL in survivors and all patients at the end of follow-up; mean areas under the HRQoL trajectories in both arms; and mean difference between areas under the HRQoL trajectories and single-sampled HRQoLs at the end of follow-up.</p><p><strong>Discussion: </strong>In the outlined simulation study, we aim to assess whether the area under the HRQoL trajectory curve could be a candidate for reconciling the seemingly paradoxical effects on improved mortality and reduced HRQoL while remaining sensitive to early or accelerated improvement in patient outcomes. The resultant insights will inform subsequent methodological work on prudent collection and statistical analysis of such data from real critically ill patients.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"122-129"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10122639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alma Nordenskjöld Syrous, Gudny Gudnadottir, Jonatan Oras, Thalia Ferguson, David Lilja, Helena Odenstedt Herges, Emma Larsson, Linda Block
{"title":"End-of-life decision-making in critically ill old patients with and without coronavirus disease 2019.","authors":"Alma Nordenskjöld Syrous, Gudny Gudnadottir, Jonatan Oras, Thalia Ferguson, David Lilja, Helena Odenstedt Herges, Emma Larsson, Linda Block","doi":"10.1111/aas.14326","DOIUrl":"10.1111/aas.14326","url":null,"abstract":"<p><strong>Background: </strong>There are few studies on the differences in end-of-life decisions making in critically ill patients with and without coronavirus disease 2019 (COVID-19). This study aimed to investigate the independent factors that predicted the decision to withdraw or withhold life-sustaining treatments (LST) in critically ill patients and if these decisions were based on different variables for critically ill patients with COVID-19 compared to those for critically ill patients with other diagnoses in a Swedish intensive care unit.</p><p><strong>Methods: </strong>This observational pilot study was performed at Sahlgrenska University Hospital, Gothenburg, Sweden. Patients ≥65 years were included from 1 March 2020 to 30 April 2021. The association between a decision to limit LST and a priori selected variables including sex, age, Simplified Acute Physiology Score 3 (SAPS 3), Clinical Frailty Scale ≥4, Charlson Comorbidity Index, Body Mass Index, living at home, invasive and non-invasive mechanical ventilation was assessed using a univariate and multivariable logistic regression model and presented as odds ratio with corresponding 95% confidence intervals.</p><p><strong>Results: </strong>There were 394 patients included in this study, 131 in the non-COVID-19 group and 263 in the COVID-19 group. For the non-COVID-19 cohort, the univariate analysis demonstrated that age and SAPS 3 were significantly associated with the decision to withdraw or withhold life-sustaining treatments, and this association remained in the multivariable analysis, with odds ratios of 1.10 (1.03-1.19) p = .009 and 1.06 (1.03-1.10) p < .001, respectively. For the COVID-19 cohort, the univariate analysis indicated that age, SAPS 3, and Charlson comorbidity index were significantly associated with the decision to withdraw or withhold life-sustaining treatments. However, in multivariable analysis, only the Charlson comorbidity index remained independently associated with the decision to withdraw or withhold life-sustaining treatments, with an odds ratio of 1.26 (1.07-1.49), p = .006.</p><p><strong>Conclusion: </strong>Decisions to withdraw or withhold life-sustaining treatments were based on other variables for the critically ill COVID-19 cohort compared to those for the critically ill non-COVID-19 cohort. Further studies are warranted to forge a common path for ethical end-of-life decision-making in critically ill patients.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"63-70"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10534274","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Continuing professional development (CPD) for anesthetists: A systematic review.","authors":"John Asger Petersen, Lucy Bray, Doris Østergaard","doi":"10.1111/aas.14306","DOIUrl":"10.1111/aas.14306","url":null,"abstract":"<p><strong>Background: </strong>In accordance with the focus on patient safety and quality in healthcare, continuing professional development (CPD) has received increasing levels of attention as a means to ensure physicians maintain their clinical competencies and are fit to practice. There is some evidence of a beneficial effect of CPD, though few studies have evaluated its effect within anesthesia. The primary aim of this systematic review was to establish which CPD activities anesthetists are engaged in and their effectiveness. The secondary aim was to explore which methods are employed to evaluate anesthetists' clinical performance.</p><p><strong>Methods: </strong>Databases searched: Medline, Embase and Web of Science, in May 2023. Additional papers were identified through searching the references of included studies. Eligible studies included anesthetists, either exclusively or combined with other healthcare professionals, who underwent a learning activity or assessment method as part of a formalized CPD program or a stand-alone activity. Non-English language studies, non-peer reviewed studies and studies published prior to 2000 were excluded. Eligible studies were quality assessed and narratively synthesized, with results presented as descriptive summaries.</p><p><strong>Results: </strong>A total of 2112 studies were identified, of which 63 were eligible for inclusion, encompassing more than 137,518 participants. Studies were primarily of quantitative design and medium quality. Forty-one studies reported outcomes of single learning activities, whilst 12 studies investigated different roles of assessment methods in CPD and ten studies evaluated CPD programs or combined CPD activities. A 36 of the 41 studies reported positive effects of single learning activities. Investigations of assessment methods revealed evidence of inadequate performance amongst anesthetists and a mixed effect of feedback. Positive attitudes and high levels of engagement were identified for CPD programs, with some evidence of a positive impact on patient/organizational outcomes.</p><p><strong>Discussion: </strong>Anesthetists are engaged in a variety of CPD activities, with evidence of high levels of satisfaction and a positive learning effect. However, the impact on clinical practice and patient outcomes remains unclear and the role of assessment is less well-defined. There is a need for further, high-quality studies, evaluating a broader range of outcomes, in order to identify which methods are most effective to train and assess specialists in anesthesia.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"2-15"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9767028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cecilie Bauer Derby, Kasper Smidt Gasbjerg, Daniel Hägi-Pedersen, Troels Haxholdt Lunn, Niels Anker Pedersen, Peter Lindholm, Stig Brorson, Henrik Morville Schrøder, Kasper Højgaard Thybo, Jens Bagger, Martin Lindberg-Larsen, Søren Overgaard, Janus Christian Jakobsen, Ole Mathiesen
{"title":"Prolonged effects of dexamethasone following total knee arthroplasty: A pre-planned sub-study of the DEX-2-TKA trial.","authors":"Cecilie Bauer Derby, Kasper Smidt Gasbjerg, Daniel Hägi-Pedersen, Troels Haxholdt Lunn, Niels Anker Pedersen, Peter Lindholm, Stig Brorson, Henrik Morville Schrøder, Kasper Højgaard Thybo, Jens Bagger, Martin Lindberg-Larsen, Søren Overgaard, Janus Christian Jakobsen, Ole Mathiesen","doi":"10.1111/aas.14319","DOIUrl":"10.1111/aas.14319","url":null,"abstract":"<p><strong>Objectives: </strong>The DEX-2-TKA trial demonstrated that one and two doses of 24 mg intravenous dexamethasone reduced opioid consumption and pain after total knee arthroplasty (TKA). We aimed to investigate the prolonged effects of dexamethasone after the 48-h intervention period.</p><p><strong>Design: </strong>This was a prospective, pre-planned questionnaire follow-up on postoperative days 3-7 of patients in the DEX-2-TKA trial that randomly received: DX1 (dexamethasone 24 mg + placebo), DX2 (dexamethasone 24 mg + dexamethasone 24 mg), and placebo (placebo + placebo) perioperatively and 24 h later.</p><p><strong>Setting: </strong>A multicenter trial performed at five Danish hospitals.</p><p><strong>Participants: </strong>We analyzed 434 of 485 adult participants enrolled in the DEX-2-TKA trial.</p><p><strong>Outcome measures: </strong>Primary outcome was difference between groups in average of all numerical rating scale (NRS) pain scores reported in the morning, at bedtime, and the daily average pain on postoperative days 3-7. Secondary outcomes were sleep quality and patient satisfaction.</p><p><strong>Results: </strong>The median (interquartile range) pain intensity levels for postoperative days 3-7 were: DX2 3.2 (2.1-4.3); DX1 3.3 (2.3-4.1); and placebo 3.3 (2.5-4.7). Hodges-Lehmann median differences between groups were: 0 (95% confidence interval - 0.54 to 0.2), P = 0.38 between DX1 and placebo; 0.1 (-0.47 to 0.33), p = .87 between DX1 and DX2; and 0.1 (-0.6 to 0.13), p = .20 between DX2 and placebo. We found no relevant differences between groups on sleep quality on postoperative days 3-7 nor for patient satisfaction with the analgesic treatment.</p><p><strong>Conclusions: </strong>We found that neither one nor two doses of 24 mg intravenous dexamethasone demonstrated prolonged effects on overall pain or sleep quality on postoperative days 3-7 after total knee arthroplasty. We also found that dexamethasone had no effect on patient satisfaction.</p><p><strong>Trial registration number: </strong>Clinicaltrials.gov NCT03506789 (main result trial).</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"35-42"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10246101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Benjamin Skov Kaas-Hansen, Anders Granholm, Praleene Sivapalan, Carl Thomas Anthon, Olav Lilleholt Schjørring, Mathias Maagaard, Maj-Brit Nørregaard Kjaer, Jesper Mølgaard, Karen Louise Ellekjaer, Steen Kåre Fagerberg, Theis Lange, Morten Hylander Møller, Anders Perner
{"title":"Real-world causal evidence for planned predictive enrichment in critical care trials: A scoping review.","authors":"Benjamin Skov Kaas-Hansen, Anders Granholm, Praleene Sivapalan, Carl Thomas Anthon, Olav Lilleholt Schjørring, Mathias Maagaard, Maj-Brit Nørregaard Kjaer, Jesper Mølgaard, Karen Louise Ellekjaer, Steen Kåre Fagerberg, Theis Lange, Morten Hylander Møller, Anders Perner","doi":"10.1111/aas.14321","DOIUrl":"10.1111/aas.14321","url":null,"abstract":"<p><strong>Background: </strong>Randomised clinical trials in critical care are prone to inconclusiveness due, in part, to undue optimism about effect sizes and suboptimal accounting for heterogeneous treatment effects. Although causal evidence from rich real-world critical care can help overcome these challenges by informing predictive enrichment, no overview exists.</p><p><strong>Methods: </strong>We conducted a scoping review, systematically searching 10 general and speciality journals for reports published on or after 1 January 2018, of randomised clinical trials enrolling adult critically ill patients. We collected trial metadata on 22 variables including recruitment period, intervention type and early stopping (including reasons) as well as data on the use of causal evidence from secondary data for planned predictive enrichment.</p><p><strong>Results: </strong>We screened 9020 records and included 316 unique RCTs with a total of 268,563 randomised participants. One hundred seventy-three (55%) trials tested drug interventions, 101 (32%) management strategies and 42 (13%) devices. The median duration of enrolment was 2.2 (IQR: 1.3-3.4) years, and 83% of trials randomised less than 1000 participants. Thirty-six trials (11%) were restricted to COVID-19 patients. Of the 55 (17%) trials that stopped early, 23 (42%) used predefined rules; futility, slow enrolment and safety concerns were the commonest stopping reasons. None of the included RCTs had used causal evidence from secondary data for planned predictive enrichment.</p><p><strong>Conclusion: </strong>Work is needed to harness the rich multiverse of critical care data and establish its utility in critical care RCTs. Such work will likely need to leverage methodology from interventional and analytical epidemiology as well as data science.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"16-25"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10495165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Monika Afzali Rubin, Sandra E S Meulengracht, Katja Anna Poulsen Frederiksen, Thordis Thomsen, Ann Merete Møller
{"title":"The healthcare professionals' perspectives and experiences with family presence during resuscitation: A qualitative evidence synthesis.","authors":"Monika Afzali Rubin, Sandra E S Meulengracht, Katja Anna Poulsen Frederiksen, Thordis Thomsen, Ann Merete Møller","doi":"10.1111/aas.14323","DOIUrl":"10.1111/aas.14323","url":null,"abstract":"<p><strong>Introduction: </strong>Family presence during resuscitation (FPDR) is a growing hospital praxis despite lack of high-quality evidence. The aim of this qualitative evidence synthesis review was to synthesize current evidence regarding healthcare professionals (HCP) perspectives on barriers and facilitating factors of FPDR and the potential impact of FPDR on HCP performance.</p><p><strong>Methods: </strong>We conducted a systematic literature search May 17, 2023 including primary studies with qualitative study designs. We applied NVivo for data analysis. Data was coded with line-by-line coding and organized into themes and categories following the method for thematic synthesis described by Thomas and Harden to analyse data. The studies underwent quality appraisal by Critical Appraisal Skills Program. We used GRADE CERQual to assess the confidence in the evidence.</p><p><strong>Results: </strong>We identified 8241 articles suitable for screening, 141 articles were full text screened, and nine studies included from Australia, UK and USA. In total, 134 HCP participated, between 2005 and 2019. Most studies lacked sufficiently rigorous data analysis and findings were appraised to have moderate GRADE CERQual confidence. We identified three analytical themes (\"Facilitating factors for FPDR\", \"Barriers for FPDR\" and \"How staff are affected by FPDR\") with eight descriptive subthemes. One finding was of high GRADE CERQual confidence: a belief that FPDR is \"the right thing to do\" which was a \"Facilitating factor of FPDR.\"</p><p><strong>Conclusion: </strong>The evidence on HCP perspectives is of low to moderate confidence. The interviewed consent that FPDR is the \"right thing to do\", and an ethical principle of beneficence is dominant, especially regarding children.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"101-121"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10533851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Linda Bergestuen, Thomas Moger, Kjersti Oterhals, Frank Pfeffer, Torunn Nestvold, Stig Norderval, Linn Såve Nymo, Kjerstin Havnes, Kristoffer Lassen, Kyrre Breivik
{"title":"Translation and validation of the Norwegian version of the postoperative quality of recovery score QoR-15.","authors":"Linda Bergestuen, Thomas Moger, Kjersti Oterhals, Frank Pfeffer, Torunn Nestvold, Stig Norderval, Linn Såve Nymo, Kjerstin Havnes, Kristoffer Lassen, Kyrre Breivik","doi":"10.1111/aas.14322","DOIUrl":"10.1111/aas.14322","url":null,"abstract":"<p><strong>Background: </strong>As patient-centered care gains more attention, assessing the patient's perspective on their recovery has become increasingly important. In response to the need for a reliable and valid patient reported outcome measurement tool for major surgical resections in Norway. The Norwegian Registry for Gastrointestinal Surgery (NORGAST) initiated a project to translate and evaluate QoR-15's psychometric properties for patients going through general, gastrointestinal (GI), and hepato-pancreato-biliary (HPB) resectional surgery.</p><p><strong>Methods: </strong>After a translation and adaption of the original version of QoR-15 into Norwegian, the QoR-15NO was psychometrically evaluated including a confirmatory factor analysis to test for unidimensionality, as well as tests for content validity, internal consistency, measurement error, construct validity, feasibility, and responsiveness. This process included cognitive interviews using a structured interview guide. Further, patients who underwent various types of GI/HPB surgery at five hospitals in different parts of Norway completed the QoR-15NO before surgery and on the first or second day after surgery. The impact of surgery was classified according to Surgical Outcome Risk Tool v2 (SORT), in extra major/complex, major, intermediate, and minor.</p><p><strong>Results: </strong>This study included 324 patients with 83% return rate with both pre- and postoperative forms. There were negative correlations between duration of surgery and postoperative QoR-15 score and the difference between post- and preoperative score (change score). Individuals who had gone through surgery with major impact had a lower postoperative mean QoR-15 score (97) than their counterparts who had experienced either medium (QoR-15: 110) or minor (QoR15: 119) impact surgery. Cronbach's alpha (0.88) and Omega Alpha Total (ωt = 0.90) indicate that the scale has good to very good internal consistency. Test-retest reliability was measured by Intra-class Correlation Coefficient to ICC = 0.70. Confirmatory factor analyses supported that a one-factor model with correlated residuals had a good fit to data.</p><p><strong>Conclusion: </strong>This study supports QoR-15NO as a valid, essentially unidimensional, feasible, and responsive instrument among patients undergoing general, GI, and HPB resectional surgery in Norway. The total QoR-15NO score provides important information that can be used in an everyday clinical setting and integrated into NORGAST.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"43-50"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10539113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sine Wichmann, Theis Lange, Anders Perner, Christian Gluud, Theis S Itenov, Rasmus E Berthelsen, Lars Nebrich, Jørgen Wiis, Anne C Brøchner, Louise G Nielsen, Meike T Behzadi, Kjeld Damgaard, Anne S Andreasen, Kristian Strand, Mikko Järvisalo, Thomas Strøm, Camilla T Eschen, Marianne L Vang, Thomas Hildebrandt, Finn H Andersen, Martin I Sigurdsson, Katrin M Thomar, Sandra K Thygesen, Thomas T Troelsen, Panu Uusalo, Ville Jalkanen, Dorte Illum, Christoffer Sølling, Frederik Keus, Carmen A Pfortmueller, Rebecka R Wahlin, Marlies Ostermann, Anders Aneman, Morten H Bestle
{"title":"Furosemide versus placebo for fluid overload in intensive care patients-The randomised GODIF trial second version: Statistical analysis plan.","authors":"Sine Wichmann, Theis Lange, Anders Perner, Christian Gluud, Theis S Itenov, Rasmus E Berthelsen, Lars Nebrich, Jørgen Wiis, Anne C Brøchner, Louise G Nielsen, Meike T Behzadi, Kjeld Damgaard, Anne S Andreasen, Kristian Strand, Mikko Järvisalo, Thomas Strøm, Camilla T Eschen, Marianne L Vang, Thomas Hildebrandt, Finn H Andersen, Martin I Sigurdsson, Katrin M Thomar, Sandra K Thygesen, Thomas T Troelsen, Panu Uusalo, Ville Jalkanen, Dorte Illum, Christoffer Sølling, Frederik Keus, Carmen A Pfortmueller, Rebecka R Wahlin, Marlies Ostermann, Anders Aneman, Morten H Bestle","doi":"10.1111/aas.14320","DOIUrl":"10.1111/aas.14320","url":null,"abstract":"<p><strong>Background: </strong>Fluid overload is associated with increased mortality in intensive care unit (ICU) patients. The GODIF trial aims to assess the benefits and harms of fluid removal with furosemide versus placebo in stable adult patients with moderate to severe fluid overload in the ICU. This article describes the detailed statistical analysis plan for the primary results of the second version of the GODIF trial.</p><p><strong>Methods: </strong>The GODIF trial is an international, multi-centre, randomised, stratified, blinded, parallel-group, pragmatic clinical trial, allocating 1000 adult ICU patients with moderate to severe fluid overload 1:1 to furosemide versus placebo. The primary outcome is days alive and out of hospital within 90 days post-randomisation. With a power of 90% and an alpha level of 5%, we may reject or detect an improvement of 8%. The primary analyses of all outcomes will be performed in the intention-to-treat population. For the primary outcome, the Kryger Jensen and Lange method will be used to compare the two treatment groups adjusted for stratification variables supplemented with sensitivity analyses in the per-protocol population and with further adjustments for prognostic variables. Secondary outcomes will be analysed with multiple linear regressions, logistic regressions or the Kryger Jensen and Lange method as suitable with adjustment for stratification variables.</p><p><strong>Conclusion: </strong>The GODIF trial data will increase the certainty about the effects of fluid removal using furosemide in adult ICU patients with fluid overload.</p><p><strong>Trial registrations: </strong>EudraCT identifier: 2019-004292-40 and ClinicalTrials.org: NCT04180397.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"130-136"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10570410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Stine Uhrenholt, Signe Maria Linér, Jannik Stokholm, Thomas Christensen, Morten H Bestle
{"title":"Pupillary dilation velocity is reduced in intensive care unit patients with septic shock.","authors":"Stine Uhrenholt, Signe Maria Linér, Jannik Stokholm, Thomas Christensen, Morten H Bestle","doi":"10.1111/aas.14327","DOIUrl":"10.1111/aas.14327","url":null,"abstract":"<p><strong>Background: </strong>Septic shock is common in the intensive care unit (ICU). The pathophysiology is poorly understood but prolonged sympathetic activation leading to autonomic dysfunction may be involved. Pupillary light response (PLR) is a fast, inexpensive, noninvasive way to measure autonomic nervous system function. The aim of the study was to observe dilation velocity of the PLR (PLR<sub>dil.vel.</sub> ) in patients with and without septic shock and explore whether other factors influenced the possible association. We hypothesized that the presence of septic shock in intensive care patients is associated with changes in sympathetic autonomic tone, which can be observed as changes in PLR<sub>dil.vel.</sub> METHODS: In this prospective observational cohort study, we included 91 adult patients acutely admitted to a mixed ICU. The patients were followed for the development of septic shock until ICU discharge. PLR<sub>dil.vel.</sub> was measured with a portable pupillometer two times a day. We used linear mixed models to analyze for an association between PLR<sub>dil.vel</sub> and septic shock along with several covariables.</p><p><strong>Results: </strong>Ninety-one patients were enrolled and of these, 35 were in septic shock. Septic shock was associated with a slowed PLR<sub>dil.vel</sub> of 0.3 mm/s (95% confidence intervals [CI -0.4; -0.2]).</p><p><strong>Conclusions: </strong>Septic shock may be associated with changes in sympathetic autonomic tone which is supported by the findings from this study that septic shock was associated with a slower dilation velocity in the pupillary light reflex. Further studies should examine if the pupillary dilation velocity may serve as surrogate marker for changes in sympathetic autonomic nervous system activity in intensive care patients in septic shock. If so, future interventional studies should test if use of the pupillary dilation velocity may be used for earlier detection of septic shock, which could mean earlier institution of treatment measures for this condition.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"56-62"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10313385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pedro Hilton de Andrade Filho, Victor Egypto Pereira, Daniel da Escossia Melo Sousa, Ladyer da Gama Costa, Yuri Pinto Nunes, Giovani Taglialegna, Waynice Neiva de Paula-Garcia, Joao Manoel Silva
{"title":"Analgesic efficacy of erector spinae plane block versus paravertebral block in lung surgeries-A non-inferiority randomised controlled trial.","authors":"Pedro Hilton de Andrade Filho, Victor Egypto Pereira, Daniel da Escossia Melo Sousa, Ladyer da Gama Costa, Yuri Pinto Nunes, Giovani Taglialegna, Waynice Neiva de Paula-Garcia, Joao Manoel Silva","doi":"10.1111/aas.14325","DOIUrl":"10.1111/aas.14325","url":null,"abstract":"<p><strong>Background: </strong>Pain management plays an essential role in postoperative recovery after lung surgeries. The Erector Spinae Plane Block (ESPB) is a widely used regional anaesthesia technique; however, few clinical trials have compared this block to active control in thoracic surgeries. This study evaluated the non-inferiority of the analgesia provided by ESPB when compared to paravertebral block (PVB) in lung surgeries.</p><p><strong>Methods: </strong>Randomised, active-controlled, blinded for patients and assessors, non-inferiority trial. Patients who underwent unilateral lung surgeries were divided into two groups according to the regional anaesthesia technique-continuous ESPB or PVB at the T5 level. The primary outcome was to assess pain using a numerical rating scale (NRS) with a test of the interaction of three measures over 24 h postoperatively. An NRS score ≥ 7 was considered analgesia failure, and the prespecified non-inferiority margin was 10%.</p><p><strong>Results: </strong>In the interim analysis that terminated this study, 120 participants were enrolled. ESPB patients reported higher mean NRS general values over 24 h, 4.6 ± 3.2 in the ESPB group versus 3.9 ± 2.9 in the PVB group, with a difference of -0.67 (-15.2%) and 95%CI: -1.29 to -0.05 (p = .02), demonstrating not non-inferiority. In addition, the ESPB group presented higher NRS failure of analgesia over 24 h (p < .01) and required more postoperative opioids (p = .01 over 24 h). There was no difference in patient satisfaction between groups.</p><p><strong>Conclusion: </strong>This trial demonstrated that a continuous erector spinae plane block was not non-inferior to a continuous paravertebral block for analgesia after lung surgery but resulted in higher levels of postoperative pain and opioid consumption.</p>","PeriodicalId":6909,"journal":{"name":"Acta Anaesthesiologica Scandinavica","volume":" ","pages":"71-79"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10104311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}