Open Lung Protective Ventilation in Cardiac Surgery (PROVECS)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Hypoxemia

Treatments: Procedure: Open lung protective ventilation strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT02866578

2016-A00352-49 (Other Identifier)

2016-03

Details and patient eligibility

About

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.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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494 participants in 2 patient groups

Open lung protective ventilation

Experimental group

Description:

* Recruitment maneuvers (30 cmH2O during 30 seconds) after intubation, after CPB initiation, before aortic declamping and at ICU arrival. * PEEP at 8 cmH2O. * Ultraprotective ventilation during CPB: PEEP 8 cmH2O, Tidal volume 3mL/kg, Respiratory rate 12 cycles per minute, FiO2 40%. * Assigned intervention - Procedure: patients are randomized and ventilated with the open lung strategy from intubation to detubation.

Treatment:

Procedure: Open lung protective ventilation strategy

Conventional strategy

No Intervention group

Description:

No recruitment maneuvers. PEEP at 2 cmH2O. During CPB: continuous positive pressure at 2 cmH2O.