Skip to main content
OpenTrials
Completed

NCT Number: NCT02866578

Open Lung Protective Ventilation in Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open lung protective ventilation strategy

Procedure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. ICU free Days

    Time frame: First 7 days post operatively

    Days alive and free from the need of intensive care

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: PROVECS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2016
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.