Open Lung Protective Ventilation in Cardiac Surgery

Hypoxemia Clinical Trial

— PROVECS  

Official title:

Open Lung Protective Ventilation During Cardiac Surgery With Cardiopulmonary Bypass : a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866578
• Other study ID #: 2016-03
• Secondary ID: 2016-A00352-49
• Status: Completed
• Phase: N/A
• Start date: September 23, 2016
• Est. completion date: May 7, 2018

Study information

• Verified date: December 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: May 7, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

Procedure:
• Open lung protective ventilation strategy

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Hôpital Louis Pradel HCL	Lyon
France	Assistance Publique Hopitaux de Marseille	Marseille
France	CHU MontpellierHôpital Arnaud de VILLENEUVE	Montpellier
France	Hôpital Européen Georges Pompidou AP-HP	Paris
France	CHU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pulmonary complications defined as a composite endpoint	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	first 7 days post-operatively.
Secondary	Postoperative extrapulmonary complication	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	First 7 days post operatively
Secondary	ICU free Days	Days alive and free from the need of intensive care	First 7 days post operatively