Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial
2019
Lagier, David | Fischer, François | Fornier, William | Huynh, Thi Mum | Cholley, Bernard | Guinard, Benoit | Heger, Bob | Quintana, Gabrielle | Villacorta, Judith | Gaillat, Francoise | Gomert, Romain | Degirmenci, Su | Colson, Pascal | Lalande, Marion | Benkouiten, Samir | Minh, Tam Hoang | Pozzi, Matteo | Collart, Frederic | Latremouille, Christian | Vidal Melo, Marcos | Velly, Lionel | Jaber, Samir | Fellahi, Jean-Luc | Baumstarck, Karine | Guidon, Catherine | Hôpital de la Timone [CHU - APHM] (TIMONE) | Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN) ; Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) | Nouvel Hôpital Civil de Strasbourg ; Les Hôpitaux Universitaires de Strasbourg (HUS) | Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN) ; Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL) ; Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon) ; Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM) | Hospices Civils de Lyon, Hôpital Louis Pradel, Lyon, France. | Hôpital Européen Georges Pompidou [APHP] (HEGP) ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO) | Service d'Anesthésie-Réanimation [CHU HEGP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP) ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO) | Les Hôpitaux Universitaires de Strasbourg (HUS) | Service Anesthésie et Réanimation [Hôpital Nord - APHM] ; Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital Nord [CHU - APHM] | Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier) | Institut de Génomique Fonctionnelle (IGF) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS) | Assistance Publique - Hôpitaux de Marseille (APHM) | Carnegie Mellon University [Pittsburgh] (CMU) | Hôpital Louis Pradel [CHU - HCL] ; Hospices Civils de Lyon (HCL) | Department of Cardiac Surgery ; Hôpital Européen Georges Pompidou [APHP] (HEGP) ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO) | Massachusetts General Hospital, Harvard Medical School, Boston, USA. 17 | Institut de Neurosciences de la Timone (INT) ; Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS) | Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS) | Université Claude Bernard Lyon 1 (UCBL) ; Université de Lyon | Faculté de Médecine, Aix-Marseille Université, Marseille, France. | Aix Marseille Université (AMU) | Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS) ; Aix Marseille Université (AMU)
International audience
Show more [+] Less [-]English. 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.
Show more [+] Less [-]English. Clinicaltrials.gov Identifier: NCT02866578. https://clinicaltrials.gov/ct2/show/NCT02866578.
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