Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery

NCT03372174 | Completed DMC

• 2 other identifiers: 35RC16_9908_VECAR2017-A01246-47
• Study Type: interventional
• Target: 1,401
• Locations: 1 country
• Sites: 6

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.

Conditions

Cardiopulmonary Bypass

Keywords

cardiac surgery; mechanical ventilation; postoperative infections

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative infections

  During 28 days

Secondary Outcomes (12)

• Expression of human leukocyte antigen-DR antigen (HLA-DR)

  At day 0, day 1 and day 7

• Plasmatic concentration of interleukin 10 (IL10)

  At day 0, day 1 and day 7

• Indoleamine 2,3-Dioxygenase (IDO) activity

  At day 0, day 1 and day 7

• Proportion of myeloid-derived suppressor cells (MDSCs)

  At day 0, day 1 and day 7

• Plasmatic concentration of interleukin 6 (IL-6)

  At day 0, day 1 and day 7

Study Arms (2)

Mechanical ventilation group

EXPERIMENTAL

patients with mechanical ventilation during cardiopulmonary bypass for cardiac surgery

Device: Maintaining mechanical ventilation during surgery

Control group

ACTIVE COMPARATOR

patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery

Device: Absence of mechanical ventilation during surgery

Interventions

Maintaining mechanical ventilation during surgery 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

Mechanical ventilation group

Absence of mechanical ventilation during surgery DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (6)

CHU Angers

Angers, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Lille

Lille, France

Location

Hôpital Pitié Salpêtrière

Paris, France

Location

CHU Rennes

Rennes, France

Location

CHU Toulouse

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 40323450 DERIVED

Study Officials

• Jean-Marc TADIE

  Rennes Hospital University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 13, 2017
• Study Start: January 10, 2018
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)