Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery

NCT03098524 | Completed

• 1 other identifier: 2016/03
• Study Type: interventional
• Target: 1,502
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND. Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. To this date, there are no recommendations regarding mechanical ventilation associated with cardiopulmonary bypass (CPB) during the surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain a low-tidal volume ventilation (LTV). Indirect evidence points towards better pulmonary outcomes when LTV is performed but no proper prospective trial with large inclusion of all types of cardiac surgery has been published. DESIGN. The MECANO trial is a single-center, double-blind, randomized controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. 1500 patients will be included for whom planned cardiac surgery with CPB is performed. They will be randomized between noV and LTV, on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 acts/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. Primary endpoint will be composite of overall death, early respiratory failure defined as PaO2/FiO2 ratio \<200 mmHg at one-hour after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either non-invasive ventilation, mechanical ventilation or high flow oxygen) at 2 days after arrival in the ICU or ventilator acquired pneumoniae defined by Center of Disease Control. Lung recruitment manoeuvers will be performed for noV and LTV groups, at the end of surgery and at the arrival in ICU with an insufflation at +30 cmH20 during 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cells transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge. SUMMARY. The MECANO trial compares a no-ventilation to a low-tidal volume strategy for mechanical ventilation during cardiac surgery with CPB, regarding a primary composite outcome including death, respiratory failure and pneumoniae.

Conditions

Atelectasis; Pneumonia; Pneumothorax; Bleeding; Surgery--Complications; Cardiac Disease; Respiratory Failure

Keywords

Cardiac surgery; Mechanical ventilation; Cardiopulmonary bypass; Pneumonia; Atelectasis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality or early respiratory failure or Late respiratory failure or Ventilator acquired pneumonia and early pneumonia

  Composite outcome with all-cause in-hospital mortality, early respiratory failure defined as PaO2/FiO2 ratio \<200 at the first hour after transfer in ICU after surgery, late respiratory failure defined as heavy oxygenation support (non-invasive ventilation, high flow oxygen or mechanical ventilation) two days after surgery and pneumonia (early or ventilator acquired) defined by Center of Disease Control (CDC) criteria (2016 guidelines).

  From date of randomization until the date of first documented event or date of death from any cause, whichever came first, assessed up to 24 months.

Secondary Outcomes (7)

• All-cause in-hospital mortality

  From date of randomization until date of death from any cause, assessed up to 24 months.

• Early respiratory failure

  Assessed at one hour after transfer in postoperative ICU

• heavy oxygenation support

  Assessed 2 days after surgery

• Pneumonia (early or ventilator-acquired)

  From date of randomization until the date of first documented event, assessed up to 24 months.

• Length of stay in the ICU

  Assessed at the end of hospitalization, through study completion, assessed up to 24 months.

Other Outcomes (5)

• Revision surgery

  From date of randomization until the date of first documented event, assessed up to 24 months.

• Pneumothorax

  From date of randomization until the date of first documented event, assessed up to 24 months.

• Postoperative bleeding

  Assessed at the end of hospitalization, through study completion, assessed up to 24 months.

Study Arms (2)

Low tidal volume ventilation (LTV arm)

EXPERIMENTAL

During cardiopulmonary bypass, mechanical ventilation is maintained with 5 acts/minute, tidal volume = 3 ml/kg (ideal body weight) with positive end-expiratory pressure = 5 cmH2O

Procedure: Low tidal volume ventilation (LTV arm); Procedure: Lung recruitment manoeuver

No ventilation (noV arm)

PLACEBO COMPARATOR

No mechanical ventilation during cardiopulmonary bypass.

Procedure: No ventilation (noV arm); Procedure: Lung recruitment manoeuver

Interventions

Low tidal volume ventilation (LTV arm) PROCEDURE

During cardiopulmonary bypass, mechanical ventilation is maintained with settings described above.

Low tidal volume ventilation (LTV arm)

No ventilation (noV arm) PROCEDURE

During cardiopulmonary bypass, no mechanical ventilation is performed.

No ventilation (noV arm)

Lung recruitment manoeuver PROCEDURE

An insufflation with positive end-expiratory pressure +30 cmH20 during 5 seconds. At the end of cardiopulmonary bypass, in the operative room. And after transfer to the ICU (intensive care unit).

Low tidal volume ventilation (LTV arm); No ventilation (noV arm)

Eligibility Criteria

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

You may qualify if:

• more than 18 years old
• ability to provide an informed consent
• planned surgery
• surgical intervention with cardio-pulmonary bypass, aortic clamp and cardioplegia.

You may not qualify if:

• impossibility to wean CPB at the end of cardiac surgery

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Related Publications (6)

• Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.

  PMID: 21045639 BACKGROUND

• Bignami E, Guarnieri M, Saglietti F, Belletti A, Trumello C, Giambuzzi I, Monaco F, Alfieri O. Mechanical Ventilation During Cardiopulmonary Bypass. J Cardiothorac Vasc Anesth. 2016 Dec;30(6):1668-1675. doi: 10.1053/j.jvca.2016.03.015. Epub 2016 Mar 9. No abstract available.

  PMID: 27468893 BACKGROUND

• Schreiber JU, Lance MD, de Korte M, Artmann T, Aleksic I, Kranke P. The effect of different lung-protective strategies in patients during cardiopulmonary bypass: a meta-analysis and semiquantitative review of randomized trials. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):448-54. doi: 10.1053/j.jvca.2012.01.034. Epub 2012 Mar 28.

  PMID: 22459933 BACKGROUND

• Nguyen LS, Estagnasie P, Merzoug M, Brusset A, Law Koune JD, Aubert S, Waldmann T, Naudin C, Grinda JM, Gibert H, Squara P. Low Tidal Volume Mechanical Ventilation Against No Ventilation During Cardiopulmonary Bypass in Heart Surgery (MECANO): A Randomized Controlled Trial. Chest. 2021 May;159(5):1843-1853. doi: 10.1016/j.chest.2020.10.082. Epub 2020 Nov 17.

  PMID: 33217416 RESULT

• Boussion K, Tremey B, Gibert H, Koune JL, Aubert S, Balcon L, Nguyen LS. Efficacy of maintaining low-tidal volume mechanical ventilation as compared to resting lung strategy during coronary artery bypass graft cardiopulmonary bypass surgery: A post-hoc analysis of the MECANO trial. J Clin Anesth. 2023 Feb;84:110991. doi: 10.1016/j.jclinane.2022.110991. Epub 2022 Nov 5.

  PMID: 36347196 RESULT

• Nguyen LS, Merzoug M, Estagnasie P, Brusset A, Law Koune JD, Aubert S, Waldmann T, Grinda JM, Gibert H, Squara P. Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):582. doi: 10.1186/s13063-017-2321-9.

  PMID: 29197407 DERIVED

Related Links

• Center of Disease Control pneumonia criteria, 2016 update

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Atelectasis; Pneumonia; Pneumothorax; Hemorrhage; Heart Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Infections; Infections; Pleural Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Study Officials

• Lee S Nguyen, MD, MSc

  CMC Ambroise Paré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients are ventilated or not during the time they are sedated, so they are blind to their study arm. Anesthesiologists perform mechanical ventilation or not during cardiopulmonary bypass and log per-operative data (such as number of insufflations) on a separate leaflet of the eCRF. Investigators (cardiologists and critical care specialists) are not aware of the treatment arm as it is performed during surgery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 31, 2017
• Study Start: May 2, 2017
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: April 8, 2026

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)