{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T16:47:31Z","timestamp":1793638051833,"version":"4.5.1"},"reference-count":27,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,3,6]],"date-time":"2024-03-06T00:00:00Z","timestamp":1709683200000},"content-version":"unspecified","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Direction G\u00e9n\u00e9rale de l'offre de Soins","award":["PHRC-20-0653"],"award-info":[{"award-number":["PHRC-20-0653"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,2,2]]},"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control \u2018on-demand\u2019 arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental \u2018systematic\u2019 arm, VA-ECMO will be pre-emptively initiated. We hypothesise a \u2018systematic\u2019 strategy will increase the number of ventilatory-free days at day 28.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>The sponsor is the Assistance Publique\u2013H\u00f4pitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comit\u00e9 de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05664204\">NCT05664204<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2023-077770","type":"journal-article","created":{"date-parts":[[2024,3,6]],"date-time":"2024-03-06T05:41:24Z","timestamp":1709703684000},"page":"e077770","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05664204","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2123-3527","authenticated-orcid":false,"given":"Jonathan","family":"Messika","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippine","family":"Eloy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Boulate","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aude","family":"Charvet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julien","family":"Fessler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques","family":"Jougon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Lacoste","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olaf","family":"Mercier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Portran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hadrien","family":"Roze","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edouard","family":"Sage","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques","family":"Thes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francois","family":"Tronc","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mickael","family":"Vourc'h","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Montravers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yves","family":"Castier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herve","family":"Mal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Mordant","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,3,5]]},"reference":[{"key":"2024043021502841000_14.3.e077770.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.healun.2017.07.021"},{"key":"2024043021502841000_14.3.e077770.2","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1097\/ACO.0000000000000806","article-title":"Circulatory support during lung transplantation","volume":"33","author":"Kiziltug","year":"2020","journal-title":"Curr Opin Anaesthesiol"},{"key":"2024043021502841000_14.3.e077770.3","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1007\/s11748-017-0836-3","article-title":"Extracorporeal membrane oxygenation versus cardiopulmonary bypass during lung transplantation: a meta-analysis","volume":"66","author":"Magouliotis","year":"2018","journal-title":"Gen Thorac Cardiovasc Surg"},{"key":"2024043021502841000_14.3.e077770.4","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1016\/j.healun.2015.08.016","article-title":"Five-year experience with intraoperative extracorporeal membrane oxygenation in lung transplantation: indications and Midterm results","volume":"35","author":"Ius","year":"2016","journal-title":"J Heart Lung Transplant"},{"key":"2024043021502841000_14.3.e077770.5","doi-asserted-by":"crossref","first-page":"1167","DOI":"10.1016\/j.athoracsur.2020.03.077","article-title":"Is extracorporeal membrane oxygenation withdrawal a safe option after double-lung transplantation","volume":"110","author":"Fessler","year":"2020","journal-title":"Ann Thorac Surg"},{"key":"2024043021502841000_14.3.e077770.6","doi-asserted-by":"crossref","first-page":"178","DOI":"10.1093\/ejcts\/ezx212","article-title":"Lung transplantation for idiopathic pulmonary arterial hypertension on intraoperative and postoperatively prolonged extracorporeal membrane oxygenation provides optimally controlled reperfusion and excellent outcome","volume":"53","author":"Moser","year":"2018","journal-title":"Eur J Cardiothorac Surg"},{"key":"2024043021502841000_14.3.e077770.7","doi-asserted-by":"crossref","first-page":"2193","DOI":"10.1016\/j.jtcvs.2017.10.144","article-title":"Intraoperative extracorporeal membrane oxygenation and the possibility of postoperative prolongation improve survival in bilateral lung transplantation","volume":"155","author":"Hoetzenecker","year":"2018","journal-title":"J Thorac Cardiovasc Surg"},{"key":"2024043021502841000_14.3.e077770.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejcts.2006.11.049"},{"key":"2024043021502841000_14.3.e077770.9","doi-asserted-by":"crossref","first-page":"915","DOI":"10.1016\/j.healun.2020.04.020","article-title":"Long-term outcomes after intraoperative extracorporeal membrane oxygenation during lung transplantation","volume":"39","author":"Ius","year":"2020","journal-title":"J Heart Lung Transplant"},{"key":"2024043021502841000_14.3.e077770.10","doi-asserted-by":"crossref","first-page":"320","DOI":"10.1016\/j.jtcvs.2019.10.155","article-title":"Bilateral lung transplantation on intraoperative extracorporeal membrane oxygenator: an observational study","volume":"160","author":"Hoetzenecker","year":"2020","journal-title":"J Thorac Cardiovasc Surg"},{"key":"2024043021502841000_14.3.e077770.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2020.02.010"},{"key":"2024043021502841000_14.3.e077770.12","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"2024043021502841000_14.3.e077770.13","doi-asserted-by":"crossref","DOI":"10.3390\/jcm5110093","article-title":"Air embolism: practical tips for prevention and treatment","volume":"5","author":"McCarthy","year":"2016","journal-title":"J Clin Med"},{"key":"2024043021502841000_14.3.e077770.14","doi-asserted-by":"crossref","first-page":"259","DOI":"10.1016\/j.accpm.2017.08.007","article-title":"Veno-arterial-ECMO in the intensive care unit: from technical aspects to clinical practice","volume":"37","author":"Le Gall","year":"2018","journal-title":"Anaesth Crit Care Pain Med"},{"key":"2024043021502841000_14.3.e077770.15","doi-asserted-by":"crossref","first-page":"548","DOI":"10.1016\/j.healun.2018.01.1309","article-title":"ISHLT consensus statement on adult and pediatric airway complications after lung transplantation: definitions, grading system, and therapeutics","volume":"37","author":"Crespo","year":"2018","journal-title":"J Heart Lung Transplant"},{"key":"2024043021502841000_14.3.e077770.16","doi-asserted-by":"publisher","DOI":"10.1093\/ejcts\/ezt499"},{"key":"2024043021502841000_14.3.e077770.17","doi-asserted-by":"publisher","DOI":"10.1016\/0196-6553(88)90053-3"},{"key":"2024043021502841000_14.3.e077770.18","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.00096-2019","article-title":"Impact of donor, recipient and matching on survival after high emergency lung transplantation in France","volume":"54","author":"Roussel","year":"2019","journal-title":"Eur Respir J"},{"key":"2024043021502841000_14.3.e077770.19","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1097\/TP.0000000000003508","article-title":"COVID-19 in lung transplant recipients","volume":"105","author":"Messika","year":"2021","journal-title":"Transplantation"},{"key":"2024043021502841000_14.3.e077770.20","doi-asserted-by":"crossref","DOI":"10.1186\/1745-6215-11-79","article-title":"Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres","volume":"11","author":"Kuchinke","year":"2010","journal-title":"Trials"},{"key":"2024043021502841000_14.3.e077770.21","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1513\/pats.200808-083GO","article-title":"Surgical techniques: lung transplant and lung volume reduction","volume":"6","author":"Boasquevisque","year":"2009","journal-title":"Proc Am Thorac Soc"},{"key":"2024043021502841000_14.3.e077770.22","doi-asserted-by":"crossref","first-page":"1995","DOI":"10.1053\/j.jvca.2018.10.007","article-title":"The evolving role of extracorporeal membrane oxygenation in lung transplantation: implications for anesthetic management","volume":"33","author":"Moreno Garijo","year":"2019","journal-title":"J Cardiothorac Vasc Anesth"},{"key":"2024043021502841000_14.3.e077770.23","doi-asserted-by":"crossref","unstructured":"SRLF, SFAR . n.d. Sevrage de la ventilation M\u00e9canique (\u00c0 L\u2019Exclusion Du Nouveau-N\u00e9 et Du R\u00e9veil D\u2019Anesth\u00e9sie) - Xxie Conf\u00e9rence de consensus en R\u00e9animation et M\u00e9decine D\u2019Urgence. R\u00e9animation;10:699\u2013781.","DOI":"10.1016\/S1624-0693(01)00199-2"},{"key":"2024043021502841000_14.3.e077770.24","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000001091"},{"key":"2024043021502841000_14.3.e077770.25","doi-asserted-by":"publisher","DOI":"10.3109\/08037059209077502"},{"key":"2024043021502841000_14.3.e077770.26","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199701233360422"},{"key":"2024043021502841000_14.3.e077770.27","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2006.07.040"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-077770","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T04:53:58Z","timestamp":1714539238000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-077770"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3]]},"references-count":27,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2024,3,5]]},"published-print":{"date-parts":[[2024,3]]}},"alternative-id":["10.1136\/bmjopen-2023-077770"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-077770","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3]]}}}