Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial

David Lagier (1, 1, 2) , François Fischer (3) , William Fornier (4, 5) , Thi Mum Huynh (6) , Bernard Cholley (7, 6) , Benoit Guinard (1) , Bob Heger (8) , Gabrielle Quintana (9, 1) , Judith Villacorta (1) , Francoise Gaillat (1) , Romain Gomert (1) , Su Degirmenci (1) , Pascal Colson (10, 11) , Marion Lalande (10) , Samir Benkouiten (12) , Tam Hoang Minh (3) , Matteo Pozzi (13, 14) , Frederic Collart (12, 1) , Christian Latremouille (15, 6) , Marcos Vidal Melo (16) , Lionel Velly (12, 1, 17) , Samir Jaber (18, 10) , Jean-Luc Fellahi (4, 14, 19) , Karine Baumstarck (20, 21, 22) , Catherine Guidon (1, 1)

1 TIMONE - Hôpital de la Timone [CHU - APHM]
2 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
3 Nouvel Hôpital Civil de Strasbourg
4 CarMeN - Cardiovasculaire, métabolisme, diabétologie et nutrition
5 Hospices Civils de Lyon, Hôpital Louis Pradel, Lyon, France.
6 HEGP - Hôpital Européen Georges Pompidou [APHP]
7 Service d'Anesthésie-Réanimation [CHU HEGP]
8 HUS - Les Hôpitaux Universitaires de Strasbourg
9 Service Anesthésie et Réanimation [Hôpital Nord - APHM]
10 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
11 IGF - Institut de Génomique Fonctionnelle
12 APHM - Assistance Publique - Hôpitaux de Marseille
13 CMU - Carnegie Mellon University [Pittsburgh]
14 Hôpital Louis Pradel [CHU - HCL]
15 Department of Cardiac Surgery
16 Massachusetts General Hospital, Harvard Medical School, Boston, USA. 17
17 INT - Institut de Neurosciences de la Timone
18 PhyMedExp - Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
19 UCBL - Université Claude Bernard Lyon 1
20 Faculté de Médecine, Aix-Marseille Université, Marseille, France.
21 AMU - Aix Marseille Université
22 CEReSS - Centre d'études et de recherche sur les services de santé et la qualité de vie

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.

Clinicaltrials.gov Identifier: NCT02866578. https://clinicaltrials.gov/ct2/show/NCT02866578.

Mots clés: Open-lung ventilation; Cardiopulmonary bypass; Cardiac surgery; Recruitment maneuvers; PEEP; Postoperative pulmonary complications

Domaines: Sciences du Vivant [q-bio]

David Lagier, François Fischer, William Fornier, Thi Mum Huynh, Bernard Cholley, et al.. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial. Intensive Care Medicine, 2019, 45 (10), pp.1401-1412. ⟨10.1007/s00134-019-05741-8⟩. ⟨hal-02304312⟩