NCT02866578: PROVECS

Open Lung Protective Ventilation in Cardiac Surgery

Completed NA Last updated 20 March 2023

What this trial tests

NA trial testing Open lung protective ventilation strategy in Hypoxemia in 494 participants. Completed in 7 May 2018.

Timeline

23 September 2016

Primary endpoint
7 May 2018

7 May 2018

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	494
Start date	23 September 2016
Primary completion	7 May 2018
Estimated completion	7 May 2018
Sites	6 locations across France

Drugs / interventions tested

• Open lung protective ventilation strategy

Conditions studied

• Hypoxemia — all drugs for Hypoxemia →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

18 and older, any sex, with Hypoxemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly increase the peri-operative morbidity and require invasive treatments during longer and more expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary atelectasis seems to play a central role in the occurence of these PPCs. The open lung approach is a ventilation strategy that aims to "open the lung and keep it open" using different ventilatory settings. The efficacy of that strategy is not demonstrated in the global surgical population. However, its application in the perioperative care of cardiac surgery patients could be of great interest by counteracting the development of atelectasis.

The purpose of this multicentre, double blinded, randomized controlled study is to evaluate the influence of a perioperative multimodal protective ventilation strategy based on the "open lung approach" on postoperative outcomes during the first 7 days following cardiac surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive end expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of ultraprotective ventilation during CPB. It will be compared to a conventional approach without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary endpoint is any post-operative pulmonary complication. The secondary endpoints are any post-operative extra-pulmonary complications and the number of ICU-free days to day 7.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial.
   Lagier D, Fischer F, Fornier W, Huynh TM, et al · · 2019 · cited 57× · PMID 31576435 · DOI 10.1007/s00134-019-05741-8
2. Perioperative Open-lung Approach, Regional Ventilation, and Lung Injury in Cardiac Surgery.
   Lagier D, Velly LJ, Guinard B, Bruder N, et al · · 2020 · cited 31× · PMID 32902561 · DOI 10.1097/aln.0000000000003539
3. A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial.
   Lagier D, Fischer F, Fornier W, Fellahi JL, et al · · 2018 · cited 9× · PMID 30424770 · DOI 10.1186/s13063-018-2967-y