Open Lung Protective Ventilation in Cardiac Surgery

Not Applicable

Completed

• Conditions: Hypoxemia
• Interventions: Procedure: Open lung protective ventilation strategy

• Registration Number: NCT02866578
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Study Start: 2016-09-23
• Status Verified: 2016-12
• Primary Completion: 2018-05-07
• Study Completion: 2018-05-07
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open lung protective ventilation	Open lung protective ventilation strategy	* 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.

Primary Outcome Measures

Name	Time	Method
Post-operative pulmonary complications defined as a composite endpoint	first 7 days post-operatively.	Mild hypoxemia Moderate hypoxemia Severe hypoxemia Severe bronchospam Radiological atelectasis Respiratory acidosis Pneumonia Pleural effusion Acute Respiratory Distress Syndrome Need for reintubation Need for reintubation

Secondary Outcome Measures

Name	Time	Method
ICU free Days	First 7 days post operatively	Days alive and free from the need of intensive care
Postoperative extrapulmonary complication	First 7 days post operatively	Systemic inflammatory response syndrome Sepsis Septic chock Mediastinitis Pericardial tamponade Surgical bleeding Acute kidney failure (KDIGO stage 2 or 3) Postoperative atrial fibrillation Cardiogenic chock Delirium

Trial Locations

Locations (6)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Hôpital Louis Pradel HCL; 🇫🇷 Lyon, France

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

Hôpital Européen Georges Pompidou AP-HP; 🇫🇷 Paris, France

CHU MontpellierHôpital Arnaud de VILLENEUVE; 🇫🇷 Montpellier, France