Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery

NCT ID: NCT03372174

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2021-07-30

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 ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.

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 response, usually attributed to surgical trauma, contact of blood with artificial surfaces, and ischemia reperfusion injury, is responsible for a postoperative immunodepression. For instance, an early impairment of lung cellular immune response after CPB, which could promote the development of postoperative pneumonia, has been found. Along these lines, a downregulation of human leukocyte antigen-DR antigen (HLA-DR) expression on monocytes and an increase in plasma interleukin 10 (IL-10) associated with the occurrence of nosocomial infections have been reported. Second, CPB induces a pulmonary dysfunction, which ranges from a temporary and clinically insignificant reduction in arterial oxygenation to a life-threatening injury manifested as acute respiratory distress syndrome (ARDS). This phenomenon is of multifactorial sources, but one of the main mechanisms is the occurrence of atelectasis during surgery. Atelectasis has been associated with lung injury and release of cytokines by shear forces on alveoli and small airways. However, it is not clear whether this injury is due to a recruitment/derecruitment phenomenon (i.e., atelectrauma) or whether it might by itself lead to the release of cytokine. Since CPB mechanically circulates and oxygenates blood bypassing the heart and lungs, usual procedure during CPB is to stop mechanical ventilation (MV) (apnea). Nevertheless, maintaining MV with positive expiratory pressure (PEEP) during CPB diminished the occurrence of atelectasis and the postoperative inflammatory response. Thus, we investigated the effects of maintaining MV during CPB for cardiac surgery on postoperative immunodepression and found that maintaining MV during CPB decreased postoperative immune dysfunction and could be an interesting strategy to diminish the occurrence of postoperative infection (nosocomial infection) without hampering the surgical procedure. However, these findings have to be confirmed in a clinical trial using the incidence of nosocomial infection as an endpoint.

Conditions

Cardiopulmonary Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Mechanical ventilation group

patients with mechanical ventilation during cardiopulmonary bypass for cardiac surgery

Group Type: EXPERIMENTAL

Maintaining mechanical ventilation during surgery

Intervention Type: DEVICE

dead space ventilation using tidal volume of 2.5 mL/kg/pbw (predicted body weight) with 5-7 cm H2O Positive end-expiratory pressure

Control group

patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery

Group Type: ACTIVE_COMPARATOR

Absence of mechanical ventilation during surgery

Intervention Type: DEVICE

absence of mechanical ventilation (and no Positive end-expiratory pressure) by disconnecting the tracheal tube from the ventilator

Interventions

Maintaining mechanical ventilation during surgery

dead space ventilation using tidal volume of 2.5 mL/kg/pbw (predicted body weight) with 5-7 cm H2O Positive end-expiratory pressure

Intervention Type: DEVICE

Absence of mechanical ventilation during surgery

absence of mechanical ventilation (and no Positive end-expiratory pressure) by disconnecting the tracheal tube from the ventilator

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc TADIE

Role: PRINCIPAL_INVESTIGATOR

Rennes Hospital University

Locations

CHU Angers

Angers, , France

CHU Bordeaux

Bordeaux, , France

CHU Lille

Lille, , France

Hôpital Pitié Salpêtrière

Paris, , France

CHU Rennes

Rennes, , France

CHU Toulouse

Toulouse, , France

Countries

France

References

Tadie JM, Ouattara A, Laviolle B, Lesouhaitier M, Esvan M, Rousseau C, Gregoire M, Gaudriot B, Nesseler N, Labaste F, Sanchez P, Marcheix B, Beurton A, Dureau P, Demondion P, Fouquet O, Rineau E, Amour J, Verhoye JP, Mercat A, Terzi N, Tarte K, Bougle A, Flecher E; VECAR Trial Group and REVA. Maintaining ventilation with very low tidal volume and positive-end expiratory pressure versus no ventilation during cardiopulmonary bypass for cardiac surgery in adults: a randomized clinical trial. Intensive Care Med. 2025 May;51(5):849-860. doi: 10.1007/s00134-025-07901-5. Epub 2025 May 5.

Reference Type: DERIVED

PMID: 40323450 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-A01246-47

Identifier Type: OTHER

Identifier Source: secondary_id

35RC16_9908_VECAR

Identifier Type: -

Identifier Source: org_study_id