Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial
IntroductionLung 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...
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| Published in: | BMJ open Vol. 14; no. 3; p. e077770 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
British Medical Journal Publishing Group
05-03-2024
BMJ Publishing Group LTD BMJ Publishing Group |
| Series: | Protocol |
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| Online Access: | Get full text |
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| Abstract | IntroductionLung 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 ‘on-demand’ arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental ‘systematic’ arm, VA-ECMO will be pre-emptively initiated. We hypothesise a ‘systematic’ strategy will increase the number of ventilatory-free days at day 28.Methods and analysisWe 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.Ethics and disseminationThe sponsor is the Assistance Publique–Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.Trial registration numberNCT05664204. |
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| AbstractList | © Author(s) (or their employer(s)) 2024.Introduction 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-demandu2019 arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental u2018systematicu2019 arm, VA-ECMO will be preemptively initiated. We hypothesise a u2018systematicu2019 strategy will increase the number of ventilatory-free days at day 28. Methods and analysis 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. INTRODUCTIONLung 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 'on-demand' arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental 'systematic' arm, VA-ECMO will be pre-emptively initiated. We hypothesise a 'systematic' strategy will increase the number of ventilatory-free days at day 28.METHODS AND ANALYSISWe 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.ETHICS AND DISSEMINATIONThe sponsor is the Assistance Publique-Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.TRIAL REGISTRATION NUMBERNCT05664204. 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 'on-demand' arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental 'systematic' arm, VA-ECMO will be pre-emptively initiated. We hypothesise a 'systematic' strategy will increase the number of ventilatory-free days at day 28. 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. The sponsor is the Assistance Publique-Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals. NCT05664204. Introduction 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 ‘on-demand’ arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental ‘systematic’ arm, VA-ECMO will be pre-emptively initiated. We hypothesise a ‘systematic’ strategy will increase the number of ventilatory-free days at day 28.Methods and analysis 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.Ethics and dissemination The sponsor is the Assistance Publique–Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.Trial registration number NCT05664204. |
| Author | Musat, Andy Girault, Antoine Fessler, Julien Charvet, Aude Gallo, Eloïse Ion, Iolanda Cortier, David Goncalves, Sindia Guen, Morgan Le Roussel, Arnaud Rivory, Adrien Paternot, Alexis Roze, Hadrien Dumans, Virginie Eloy, Philippine Vourc'h, Mickael Diop, Sylvain Snauwaert, Aurélie Boulate, David Vignaux, Claire Merveilleux Du Delaporte, Amélie Seramondi, Regisse Pavec, Jérome Le Guirimand, Avit Miranda, Sandra de Brugière, Olivier Ridolfo, Jérôme Mora, Pierre Portran, Philippe Hamid, Abdul-Momen Pellerin, Christelle Glorion, Matthieu Estephan, Jerome Lacoste, Philippe Brioude, Geoffrey Roux, Antoine Drevet, Gabrielle Messika, Jonathan Josserand, Julien Tronc, Francois Atchade, Enora Finet, Michael Thumerel, Matthieu Parquin, François Repusseau, Benjamin Bon, Claire Rodriguez, Arnaud Verdière, Sylvie Colin de Devaquet, Jérôme Cassiano, Francesco Bunel, Vincent Lepoivre, Thierry Jean-Baptiste, Sylvain Fabre, Dominique Mal, Herve Menager, Jean-Baptiste Beaumont, Laurence Pastene, Bruno Groleau, Nicolas Chatron, Eva Issard, Justin Weisenburger, Gaëll |
| AuthorAffiliation | 2 Physiopathology and Epidemiology of Respiratory Diseases, UMR1152 , INSERM and Université de Paris , Paris , France 21 Service d’Anesthésie-Réanimation Chirurgie Cardiaque , Hôpital Laennec, CHU de Nantes , Nantes , France 3 Paris Transplant Group , Paris , France 19 Service de chirurgie thoracique , Hôpital Louis Pradel, Hospices Civils de Lyon , Bron , France 16 Université Paris-Saclay, INRAE, UVSQ, VIM , Jouy-en-Josas , France 22 INSERM CIC 0004 Immunologie et Infectiologie , Université de Nantes , Nantes , France 17 Department of Anesthesiology , Hôpital Marie-Lannelongue, Groupe hospitalier Paris-Saint Joseph , Le Plessis-Robinson , France 11 Service de chirurgie thoracique et cardiovasculaire , CHU Nantes , Nantes , France 13 Service d’anesthésie-réanimation , Hôpital Louis Pradel, Hospices Civils de Lyon , Bron , France 25 Service de Chirurgie Vasculaire, Thoracique et Transplantation , APHP.Nord-Université de Paris, Hôpital Bichat-Claude Bernard , Paris , France 8 Department of Anesthe |
| AuthorAffiliation_xml | – name: 22 INSERM CIC 0004 Immunologie et Infectiologie , Université de Nantes , Nantes , France – name: 6 Service de chirurgie thoracique, des maladies de l’œsophage et de transplantation pulmonaire , Assistance Publique Hopitaux de Marseille, Hôpital Nord , Marseille , France – name: 12 Department of Thoracic and Vascular Surgery and Heart-Lung Transplantation , Hôpital Marie-Lannelongue, Groupe Hospitalier Paris-Saint Joseph , Le Plessis Robinson , France – name: 4 Département d'épidémiologie, Biostatistiques et Recherche Clinique, Hôpital Bichat, AP-HP Nord, Université de Paris , Hôpital Bichat Claude-Bernard , Paris , France – name: 24 Département d’Anesthésie et Réanimation, DMU PARABOL , APHP.Nord-Université de Paris, Hôpital Bichat-Claude Bernard , Paris , France – name: 11 Service de chirurgie thoracique et cardiovasculaire , CHU Nantes , Nantes , France – name: 1 Service de Pneumologie B et Transplantation Pulmonaire , APHP.Nord-Université de Paris, Hôpital Bichat-Claude Bernard , Paris , France – name: 16 Université Paris-Saclay, INRAE, UVSQ, VIM , Jouy-en-Josas , France – name: 3 Paris Transplant Group , Paris , France – name: 14 Department of Anesthesiology and Critical Care , Haut-Leveque Hospital, Bordeaux University Hospital , Pessac , France – name: 17 Department of Anesthesiology , Hôpital Marie-Lannelongue, Groupe hospitalier Paris-Saint Joseph , Le Plessis-Robinson , France – name: 19 Service de chirurgie thoracique , Hôpital Louis Pradel, Hospices Civils de Lyon , Bron , France – name: 20 Université Claude Bernard, Lyon 1 , Lyon , France – name: 25 Service de Chirurgie Vasculaire, Thoracique et Transplantation , APHP.Nord-Université de Paris, Hôpital Bichat-Claude Bernard , Paris , France – name: 18 Cardiothoracic Intensive Care Unit , Hôpital Marie-Lannelongue, Groupe Hospitalier Paris-Saint Joseph , Le Plessis-Robinson , France – name: 2 Physiopathology and Epidemiology of Respiratory Diseases, UMR1152 , INSERM and Université de Paris , Paris , France – name: 10 Department of Thoracic Surgery , Haut-Leveque Hospital, Bordeaux University , Pessac , France – name: 9 Université Versailles-Saint-Quentin-en-Yvelines , Versailles , France – name: 5 INSERM CIC-EC1425 , Hôpital Bichat , Paris , France – name: 21 Service d’Anesthésie-Réanimation Chirurgie Cardiaque , Hôpital Laennec, CHU de Nantes , Nantes , France – name: 15 Department of Thoracic Surgery and Lung Transplantation , Hopital Foch , Suresnes , France – name: 7 Service d’Anesthésie et de Réanimation , Hôpital Nord, Assistance Publique Hôpitaux de Marseille , Marseille , France – name: 8 Department of Anesthesiology , Hôpital Foch , Suresnes , France – name: 13 Service d’anesthésie-réanimation , Hôpital Louis Pradel, Hospices Civils de Lyon , Bron , France – name: 23 Unité INSERM UMR 1152 , UFR de Médecine Xavier Bichat , Paris , France |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38448059$$D View this record in MEDLINE/PubMed https://hal.science/hal-04615255$$DView record in HAL |
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| Copyright | Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2024 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. Attribution - NonCommercial Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2024 |
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| Snippet | IntroductionLung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal... Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane... INTRODUCTIONLung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal... © Author(s) (or their employer(s)) 2024.Introduction Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung... Introduction Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal... |
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| SubjectTerms | Adult anaesthesia Clinical trials Extracorporeal membrane oxygenation Life Sciences Lung transplants Medical imaging Mortality Randomized Controlled Trial Surgery Thoracic surgery Transplant surgery Ventilators |
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| Title | Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial |
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