Status:
COMPLETED
Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery
Lead Sponsor:
Rennes University Hospital
Conditions:
Cardiopulmonary Bypass
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilat...
Detailed Description
Cardiopulmonary bypass (CBP) during cardiac surgery induces a systemic inflammatory response associated with an immune dysregulation and a significant pulmonary dysfunction. First, the inflammatory re...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old;
- Scheduled for any cardiac surgery (elective surgery) with cardio-pulmonary bypass, aortic clamp and cardioplegia, with median sternotomy and bi-pulmonary ventilation (cardiac valvular surgery (valve replacement or repair), coronary artery surgery, ascending aortic surgery and/or combined);
- Written informed consent.
Exclusion
- Emergency surgery ;
- Planned thoracotomy with one lung ventilation ;
- Patients with known respiratory diseases (current respiratory infections, asthma, chronic obstructive or restrictive pulmonary disease, obstructive apnea syndrome) ;
- Patients already intubated in the peri-operative period ;
- Immunodepression defined by proven humoral or cellular deficiency, by continuous administration of steroids at any dose for more than one month prior to hospitalization, high-dose steroids (\> 15 mg / kg / day of methylprednisolone or Equivalent), radiotherapy or chemotherapy in the previous year;;
- Need for vasopressor or inotropic agents before surgery ;
- Any acute infection in the last month before surgery ;
- Hematological disorder, autoimmune disease, immunodeficiency, immunosuppressive therapy ;
- Heart failure with an left ventricular ejection fraction\<35% ;
- Protected person (adults legally protected (under judicial protection, guardianship, or supervision), person deprived of their liberty.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
1401 Patients enrolled
Trial Details
Trial ID
NCT03372174
Start Date
January 10 2018
End Date
July 30 2021
Last Update
May 2 2022
Active Locations (6)
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1
CHU Angers
Angers, France
2
CHU Bordeaux
Bordeaux, France
3
CHU Lille
Lille, France
4
Hôpital Pitié Salpêtrière
Paris, France