Clinical trial NCT02866578: Open Lung Protective Ventilation in Cardiac Surgery
Official title: Open Lung Protective Ventilation During Cardiac Surgery With Cardiopulmonary Bypass : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Cardiac surgery planned with CPB and sternotomy.
* Age \> 18 years old.

Exclusion Criteria:

* Urgent surgery : cardiac transplantation, aortic dissection, active endocarditis.
* Aortic arch surgery with circulatory arrest.
* LVAD surgery.
* Acute or chronic preoperative hypoxemia (PaO2 \< 65 mmHg in air).
* Preoperative shock state requiring catecholamines.
* LVEF \< 40%.
* Pulmonary hypertension with systolic pulmonary artery pressure \> 50 mmHg.
* Severe right ventricular dysfunction (TDI tricuspid annular systolic velocity \< 10 cm.s-1).
* Chronic kidney disease (Glomerular filtration rate \< 30 mL/min).
* Body Mass Index \> 35kg/m2.
* Patient's refusal.

Primary outcomes:
measure: Post-operative pulmonary complications defined as a composite endpoint
timeFrame: first 7 days post-operatively.
Secondary outcomes:
measure: Postoperative extrapulmonary complication
timeFrame: First 7 days post operatively
measure: ICU free Days
timeFrame: First 7 days post operatively
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Lyon
country: France
facility: Hôpital Louis Pradel HCL
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
city: Montpellier
country: France
facility: CHU MontpellierHôpital Arnaud de VILLENEUVE
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou AP-HP
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: AP-HM
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
citation: Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. 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 Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1.
citation: Lagier D, Fischer F, Fornier W, Fellahi JL, Colson P, Cholley B, Jaber S, Baumstarck K, Guidon C; PROVECS investigators and the ARCOTHOVA group. 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. Trials. 2018 Nov 13;19(1):624. doi: 10.1186/s13063-018-2967-y.