Open Lung Protective Ventilation in Cardiac Surgery (PROVECS)

March 17, 2023 updated by: Assistance Publique Hopitaux De Marseille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

494

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux
      • Lyon, France
        • Hôpital Louis Pradel HCL
      • Marseille, France, 13354
        • Assistance Publique Hôpitaux de Marseille
      • Montpellier, France
        • CHU MontpellierHôpital Arnaud de VILLENEUVE
      • Paris, France
        • Hopital Européen Georges Pompidou AP-HP
      • Strasbourg, France
        • CHU Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open lung protective ventilation
  • 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.
Procedure: Open lung protective ventilation strategy
No Intervention: Conventional strategy
No recruitment maneuvers. PEEP at 2 cmH2O. During CPB: continuous positive pressure at 2 cmH2O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pulmonary complications defined as a composite endpoint
Time Frame: 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
first 7 days post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative extrapulmonary complication
Time Frame: 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
First 7 days post operatively
ICU free Days
Time Frame: First 7 days post operatively
Days alive and free from the need of intensive care
First 7 days post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle DESALBRES, AP-HM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2016

Primary Completion (Actual)

May 7, 2018

Study Completion (Actual)

May 7, 2018

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-03
  • 2016-A00352-49 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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