David Lagier1,2, François Fischer3, William Fornier4,5, Thi Mum Huynh6,7,8, Bernard Cholley6,7,8, Benoit Guinard9, Bob Heger3, Gabrielle Quintana9, Judith Villacorta9, Francoise Gaillat9, Romain Gomert9, Su Degirmenci9, Pascal Colson10,11, Marion Lalande10, Samir Benkouiten12, Tam Hoang Minh13, Matteo Pozzi14, Frederic Collart15, Christian Latremouille7,8, Marcos F Vidal Melo16, Lionel J Velly9,17, Samir Jaber18,19, Jean-Luc Fellahi4,20, Karine Baumstarck21, Catherine Guidon9. 1. Département d'Anesthésie et Réanimation (SAR 2), CHU La Timone, Assistance Publique des Hôpitaux de Marseille, Marseille, France. david.lagier@ap-hm.fr. 2. C2VN, Inserm 1263, Inra 1260, Aix Marseille Université, Marseille, France. david.lagier@ap-hm.fr. 3. Département d'Anesthésie et Réanimation, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France. 4. Service d'Anesthésie et Réanimation, Hospices Civils de Lyon, Hôpital Louis Pradel, Lyon, France. 5. Centre d'Investigation Clinique de Lyon, INSERM 1407, Lyon, France. 6. Service d'Anesthésie et Réanimation, Hôpital Européen Georges Pompidou, AP-HP, Paris, France. 7. Service de Chirurgie Cardiaque, Hôpital Européen Georges Pompidou, AP-HP, Paris, France. 8. Université Paris Descartes-Sorbonne Paris-Cité, Paris, France. 9. Département d'Anesthésie et Réanimation (SAR 2), CHU La Timone, Assistance Publique des Hôpitaux de Marseille, Marseille, France. 10. CHU de Montpellier, Département d'Anesthésie et Réanimation, Hôpital Arnaud de Villeneuve, Montpellier, France. 11. IGF, Cnrs, Inserm, Université de Montpellier, Montpellier, France. 12. Direction de la Recherche en Santé de l'Assistance Publique des Hôpitaux de Marseille, Marseille, France. 13. Service de Chirurgie Cardiaque, Nouvel Hôpital Civil, Strasbourg, France. 14. Service de Chirurgie Cardiaque, Hospices Civils de Lyon, Hôpital Louis Pradel, Lyon, France. 15. Service de Chirurgie Cardiaque, CHU La Timone, Assistance Publique des Hôpitaux de Marseille, Marseille, France. 16. Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, USA. 17. INT, Aix Marseille Université, Marseille, France. 18. Département d'Anesthésie et Réanimation, Hôpital Saint-Eloi, Montpellier, France. 19. UMR CNRS 9214-Inserm U1046, Université de Montpellier, Montpellier, France. 20. IHU OPERA, Inserm 1060, Faculté de Médecine Lyon Est, Université Claude Bernard Lyon 1, Lyon, France. 21. Centre d'Etudes et de Recherches sur les Services de Santé et Qualité, Faculté de Médecine, Aix-Marseille Université, Marseille, France.
Abstract
PURPOSE: To evaluate whether a perioperative open-lung ventilation strategy prevents postoperative pulmonary complications after elective on-pump cardiac surgery. METHODS: In a pragmatic, randomized, multicenter, controlled trial, we assigned patients planned for on-pump cardiac surgery to either a conventional ventilation strategy with no ventilation during cardiopulmonary bypass (CPB) and lower perioperative positive end-expiratory pressure (PEEP) levels (2 cm H2O) or an open-lung ventilation strategy that included maintaining ventilation during CPB along with perioperative recruitment maneuvers and higher PEEP levels (8 cm H2O). All study patients were ventilated with low-tidal volumes before and after CPB (6 to 8 ml/kg of predicted body weight). The primary end point was a composite of pulmonary complications occurring within the first 7 postoperative days. RESULTS: Among 493 randomized patients, 488 completed the study (mean age, 65.7 years; 360 (73.7%) men; 230 (47.1%) underwent isolated valve surgery). Postoperative pulmonary complications occurred in 133 of 243 patients (54.7%) assigned to open-lung ventilation and in 145 of 245 patients (59.2%) assigned to conventional ventilation (p = 0.32). Open-lung ventilation did not significantly reduce the use of high-flow nasal oxygenotherapy (8.6% vs 9.4%; p = 0.77), non-invasive ventilation (13.2% vs 15.5%; p = 0.46) or new invasive mechanical ventilation (0.8% vs 2.4%, p = 0.28). Mean alive ICU-free days at postoperative day 7 was 4.4 ± 1.3 days in the open-lung group vs 4.3 ± 1.3 days in the conventional group (mean difference, 0.1 ± 0.1 day, p = 0.51). Extra-pulmonary complications and adverse events did not significantly differ between groups. CONCLUSIONS: A perioperative open-lung ventilation including ventilation during CPB does not reduce the incidence of postoperative pulmonary complications as compared with usual care. This finding does not support the use of such a strategy in patients undergoing on-pump cardiac surgery. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02866578. https://clinicaltrials.gov/ct2/show/NCT02866578.
PURPOSE: To evaluate whether a perioperative open-lung ventilation strategy prevents postoperative pulmonary complications after elective on-pump cardiac surgery. METHODS: In a pragmatic, randomized, multicenter, controlled trial, we assigned patients planned for on-pump cardiac surgery to either a conventional ventilation strategy with no ventilation during cardiopulmonary bypass (CPB) and lower perioperative positive end-expiratory pressure (PEEP) levels (2 cm H2O) or an open-lung ventilation strategy that included maintaining ventilation during CPB along with perioperative recruitment maneuvers and higher PEEP levels (8 cm H2O). All study patients were ventilated with low-tidal volumes before and after CPB (6 to 8 ml/kg of predicted body weight). The primary end point was a composite of pulmonary complications occurring within the first 7 postoperative days. RESULTS: Among 493 randomized patients, 488 completed the study (mean age, 65.7 years; 360 (73.7%) men; 230 (47.1%) underwent isolated valve surgery). Postoperative pulmonary complications occurred in 133 of 243 patients (54.7%) assigned to open-lung ventilation and in 145 of 245 patients (59.2%) assigned to conventional ventilation (p = 0.32). Open-lung ventilation did not significantly reduce the use of high-flow nasal oxygenotherapy (8.6% vs 9.4%; p = 0.77), non-invasive ventilation (13.2% vs 15.5%; p = 0.46) or new invasive mechanical ventilation (0.8% vs 2.4%, p = 0.28). Mean alive ICU-free days at postoperative day 7 was 4.4 ± 1.3 days in the open-lung group vs 4.3 ± 1.3 days in the conventional group (mean difference, 0.1 ± 0.1 day, p = 0.51). Extra-pulmonary complications and adverse events did not significantly differ between groups. CONCLUSIONS: A perioperative open-lung ventilation including ventilation during CPB does not reduce the incidence of postoperative pulmonary complications as compared with usual care. This finding does not support the use of such a strategy in patients undergoing on-pump cardiac surgery. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02866578. https://clinicaltrials.gov/ct2/show/NCT02866578.
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