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Open Lung Protective Ventilation in Cardiac Surgery (PROVECS)

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ClinicalTrials.gov Identifier: NCT02866578
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hypoxemia Procedure: Open lung protective ventilation strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Open Lung Protective Ventilation During Cardiac Surgery With Cardiopulmonary Bypass : a Randomized Controlled Trial
Actual Study Start Date : September 26, 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866578


Locations
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France
CHU de Bordeaux
Bordeaux, France
Hôpital Louis Pradel HCL
Lyon, France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
CHU MontpellierHôpital Arnaud de VILLENEUVE
Montpellier, France
Hôpital Européen Georges Pompidou AP-HP
Paris, France
CHU Strasbourg
Strasbourg, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES AP-HM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02866578     History of Changes
Other Study ID Numbers: 2016-03
2016-A00352-49 ( Other Identifier: IDRCB )
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms