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Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery (MECANO)

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ClinicalTrials.gov Identifier: NCT03098524
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
CMC Ambroise Paré

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.


Condition or disease Intervention/treatment Phase
Respiratory Failure Atelectasis Pneumonia Pneumothorax Bleeding Surgery--Complications Cardiac Disease Procedure: Low tidal volume ventilation (LTV arm) Procedure: No ventilation (noV arm) Procedure: Lung recruitment manoeuver Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery : a Randomized Controlled Trial
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : August 29, 2019
Actual Study Completion Date : August 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low tidal volume ventilation (LTV arm)
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)
During cardiopulmonary bypass, mechanical ventilation is maintained with settings described above.

Procedure: Lung recruitment manoeuver

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).


Placebo Comparator: No ventilation (noV arm)
No mechanical ventilation during cardiopulmonary bypass.
Procedure: No ventilation (noV arm)
During cardiopulmonary bypass, no mechanical ventilation is performed.

Procedure: Lung recruitment manoeuver

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).





Primary Outcome Measures :
  1. All-cause mortality or early respiratory failure or Late respiratory failure or Ventilator acquired pneumonia and early pneumonia [ Time Frame: 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. ]
    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).


Secondary Outcome Measures :
  1. All-cause in-hospital mortality [ Time Frame: From date of randomization until date of death from any cause, assessed up to 24 months. ]
    All-cause in-hospital mortality

  2. Early respiratory failure [ Time Frame: Assessed at one hour after transfer in postoperative ICU ]
    PaO2/FiO2 ratio <200 at the first hour after transfer in ICU after surgery

  3. heavy oxygenation support [ Time Frame: Assessed 2 days after surgery ]
    requirement of non-invasive ventilation, high flow oxygen or mechanical ventilation

  4. Pneumonia (early or ventilator-acquired) [ Time Frame: From date of randomization until the date of first documented event, assessed up to 24 months. ]
    pneumonia (early or ventilator acquired) defined by Center of Disease Control (CDC) criteria (2016 guidelines), diagnosed while in-hospital after the cardiac surgery.

  5. Length of stay in the ICU [ Time Frame: Assessed at the end of hospitalization, through study completion, assessed up to 24 months. ]
    Length of stay in the intensive care unit (ICU) (days) after the initial cardiac surgery

  6. Length of stay in the hospital [ Time Frame: Assessed at the end of hospitalization, through study completion, assessed up to 24 months. ]
    Length of stay in the hospital (days) after the initial cardiac surgery

  7. Cost of hospitalization [ Time Frame: Assessed at the end of hospitalization, through study completion, assessed up to 24 months. ]
    Cost of hospitalization (euros)


Other Outcome Measures:
  1. Revision surgery [ Time Frame: From date of randomization until the date of first documented event, assessed up to 24 months. ]
    Requirement for any revision cardiac surgery after the initial surgery

  2. Pneumothorax [ Time Frame: From date of randomization until the date of first documented event, assessed up to 24 months. ]
    Pneumothorax diagnosed on chest x-ray or TDM occurring after the initial surgery

  3. Postoperative bleeding [ Time Frame: Assessed at the end of hospitalization, through study completion, assessed up to 24 months. ]
    Postoperative bleeding (mL)

  4. Cardiopulmonary bypass duration [ Time Frame: Assessed at the end of the initial cardiac surgery, up to 1000 minutes. ]
    Cardiopulmonary bypass duration (minutes)

  5. Red blood cells transfusion [ Time Frame: Assessed at the end of hospitalization, through study completion, assessed up to 24 months. ]
    Red blood cells transfusion (units)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

more than 18 years old

ability to provide an informed consent

planned surgery

surgical intervention with cardio-pulmonary bypass, aortic clamp and cardioplegia.

Exclusion:

impossibility to wean CPB at the end of cardiac surgery


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098524


Locations
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France
CMC Ambroise Paré
Neuilly-sur-Seine, Ile-de-France, France, 92200
Sponsors and Collaborators
CMC Ambroise Paré
Investigators
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Principal Investigator: Lee S Nguyen, MD, MSc CMC Ambroise Paré

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT03098524     History of Changes
Other Study ID Numbers: 2016/03
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CMC Ambroise Paré:
Cardiac surgery
Mechanical ventilation
Cardiopulmonary bypass
Pneumonia
Atelectasis
Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Pneumothorax
Pulmonary Atelectasis
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Pleural Diseases
Cardiovascular Diseases