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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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