{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T09:18:44Z","timestamp":1787908724651,"version":"build-2784847793"},"reference-count":48,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T00:00:00Z","timestamp":1775606400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T00:00:00Z","timestamp":1775606400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100008269","name":"L\u00e6ge Sofus Carl Emil Friis og Hustru Olga Doris Friis' Legat","doi-asserted-by":"publisher","award":["FID4401466"],"award-info":[{"award-number":["FID4401466"]}],"id":[{"id":"10.13039\/501100008269","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Anaesthesiol Scand"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Pleural effusions are common in adult intensive care unit (ICU) patients with respiratory failure. Ultrasonography\u2010guided 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\u2010ICU) feasibility trial. This is an investigator\u2010initiated, pragmatic, multicentre, open\u2010label, randomised, parallel\u2010group feasibility trial. Adults acutely admitted to the ICU with pleural effusion \u2265\u20092\u2009cm 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 &lt;\u200924\u2009h, 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\u2010guided therapeutic pleural drainage with small\u2010bore catheter, with repeated drainage of repeated pleural effusions during ICU stay including readmissions within 90\u2009days versus no therapeutic pleural drainage during ICU stay within 90\u2009days unless pre\u2010specified 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\u2009days. Secondary clinical outcomes include all\u2010cause 90\u2010day mortality, number of patients with one or more serious adverse events within 90\u2009days, and absolute number of days alive without life support and out of hospital, respectively, in 90\u2009days. Additional secondary feasibility and process outcomes will also be investigated. Data will be compared in the intension\u2010to\u2010treat population using generalised linear models adjusted for the stratification variable trial site. ClinicalTrials.gov identifier: NCT06709456. The DOPE\u2010ICU feasibility trial will assess whether randomised allocation to ultrasonography\u2010guided 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.<\/jats:p>","DOI":"10.1111\/aas.70233","type":"journal-article","created":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T05:25:49Z","timestamp":1775712349000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Drainage of Pleural Effusion in the Intensive Care Unit (\n                    <scp>DOPE<\/scp>\n                    \u2010\n                    <scp>ICU<\/scp>\n                    ) Feasibility Trial\u2014Protocol and Statistical Analysis Plan"],"prefix":"10.1111","volume":"70","author":[{"given":"Marie Schj\u00f8dt","family":"Worm","sequence":"first","affiliation":[{"name":"Department of Anaesthesia and Intensive Care Aalborg University Hospital  Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6378-9673","authenticated-orcid":false,"given":"Morten Hylander","family":"M\u00f8ller","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital\u2014Rigshospitalet  Copenhagen Denmark"},{"name":"Department of Clinical Medicine, Faculty of Health Sciences University of Copenhagen  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels Henrik","family":"Bruun","sequence":"additional","affiliation":[{"name":"Research Data and Biostatistics Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6453-6152","authenticated-orcid":false,"given":"Anne Craveiro","family":"Br\u00f8chner","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology and Intensive Care Lilleb\u00e6lt University Hospital  Kolding Denmark"},{"name":"Department of Regional Health Research Region of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6585-2659","authenticated-orcid":false,"given":"Morten Heiberg","family":"Bestle","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, Faculty of Health Sciences University of Copenhagen  Copenhagen Denmark"},{"name":"Department of Anesthesiology and Intensive Care Copenhagen University Hospital\u2014North Zealand  Hiller\u00f8d Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2190-145X","authenticated-orcid":false,"given":"Bodil Steen","family":"Rasmussen","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care Aalborg University Hospital  Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7749-6003","authenticated-orcid":false,"given":"Olav Lilleholt","family":"Schj\u00f8rring","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care Aalborg University Hospital  Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,8]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.111.4.1018"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0000000000001621"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejcdt.2016.10.005"},{"key":"e_1_2_10_5_1","first-page":"26","article-title":"Cuban Experience With Lung Ultrasound to Diagnose and Classify Pleural Effusion in Critically Ill Patients","volume":"21","author":"Cueto\u2010Medina A.","year":"2019","journal-title":"MEDICC Review"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/aas.14258"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/00063198-200307000-00008"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13613-018-0446-y"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/0885066619872449"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13089-018-0098-z"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcrc.2019.03.007"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.1990.00390160119023"},{"key":"e_1_2_10_13_1","article-title":"Efficacy and Safety Outcomes of Drainage of Intensive Care Pleural Effusions: Study Protocol for the ESODICE Randomized Controlled Trial","volume":"4","author":"Fysh E. 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