Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery : a Randomized Controlled Trial

Plain English Summary

Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery is a Not Applicable clinical trial sponsored by CMC Ambroise Paré studying Respiratory Failure, Atelectasis, Pneumonia, Pneumothorax, Bleeding, Surgery--Complications, Cardiac Disease. This trial tests two ways of breathing support for patients undergoing heart surgery with a heart-lung machine. It is for adults over 18 years old who are scheduled for planned heart surgery using a heart-lung machine. Patients will be randomly assigned to either receive a specific low-volume breathing support or no breathing support at all during the surgery. The alternative is the standard practice, which can involve either no breathing support or a low-volume breathing support during the surgery. The trial aims to enroll 1502 participants.

Official 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 MEC

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults over 18 years old who can give permission to participate. Patients scheduled for specific types of heart surgery that require a heart-lung machine. Patients who cannot be taken off the heart-lung machine at the end of surgery will not be able to join. No specific health requirements are listed beyond the need for planned heart surgery with a heart-lung machine. This trial is studying Respiratory Failure, Atelectasis, Pneumonia, Pneumothorax, Bleeding, Surgery--Complications, Cardiac Disease, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see if one breathing method is better than the other at preventing death, severe breathing problems, or pneumonia within the first 24 months after surgery. The specific primary outcome measures are: All-cause mortality or early respiratory failure or Late respiratory failure or Ventilator acquired pneumonia and early pneumonia (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.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it aims to find the best breathing strategy during heart surgery to reduce serious lung complications after the operation, a common problem that can lead to death. This research targets Respiratory Failure, Atelectasis, Pneumonia, Pneumothorax, Bleeding, Surgery--Complications, Cardiac Disease, where improved treatment options are needed.

Investor Insight

This trial addresses a significant unmet need in cardiac surgery, potentially impacting the standard of care for a large patient population and offering a competitive advantage to hospitals adopting t The large enrollment target of 1502 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the two breathing methods being compared and why one might be chosen for you. Participation involves being randomly assigned to one of the two breathing strategies during your heart surgery. You will be monitored closely after surgery for breathing complications and other outcomes. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 1,502 participants

Interventions

• PROCEDURE: Low tidal volume ventilation (LTV arm) — During cardiopulmonary bypass, mechanical ventilation is maintained with settings described above.
• 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 Outcomes

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

• 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.)

Full Eligibility 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

Trial Locations

• CMC Ambroise Paré, Neuilly-sur-Seine, Île-de-France Region, France

Frequently Asked Questions

Related Conditions

• Heart Surgery
• Cardiopulmonary Bypass
• Respiratory Failure
• Atelectasis
• Pneumonia
• Pneumothorax
• Cardiac Disease
• Postoperative Complications
• Mechanical Ventilation
• Intensive Care Unit (ICU)

More Respiratory Failure Trials

View all Respiratory Failure clinical trials