Recruiting

Mechanical VENTilation

Sponsor:

University Health Network, Toronto

Code:

NCT03288558

Conditions

Pulmonary Complications

Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

A comprehensive perioperative mechanical ventilation strategy

Study Details

Brief summary:

Heart surgery is a life-saving intervention for hundreds of thousands of patients each year worldwide. Advances in technology and medical expertise have improved outcomes for these patients over the years. However, despite such advances, approximately 30% of patients develop lung complications (also called "pulmonary complications") after heart surgery, which result in prolonged hospital stay, increased mortality and healthcare costs.

During and immediately after heart surgery, the patient's breathing needs to be artificially controlled by a breathing machine, called "mechanical ventilator". The medical literature has reported that in critically ill patients the use of specific settings on the breathing machine (so called "protective mechanical ventilation") prevents lung complications and significantly decreases mortality. Studies show that such settings could also be beneficial for patients that undergo several types of planned surgery, however data regarding heart surgery patients (the most vulnerable to lung complications) are lacking.The aim of our study is to test whether the use of protective mechanical ventilation settings during and after heart surgery reduces lung complications compared to the current standard of care. The main innovation of this study is the application of a novel protective mechanical ventilation strategy to patients undergoing cardiac surgery, in order to reduce post-operative pulmonary complications.

Conditions

Pulmonary Complications

Cardiac Surgery

Study ID

NCT03288558

Start date

Jul 7, 2017

Status verified date

Apr, 2021

Completion date

Apr 1, 2022

Anticipated

Primary completion date

Dec 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 18 years old
  • Scheduled for elective Coronary Artery Bypass Graft, Single valve repair or replacement, or Coronary Artery Bypass Graft plus Single Valve repair or replacement, with the use of Cardiopulmonary Bypass (CPB), aortic clamp and cardioplegia, sternotomy

Exclusion Criteria:

  • Pregnancy
  • Clinically significant Congenital Heart Disease
  • Surgery with planned thoracotomy approach with one lung ventilation
  • Body mass index (the weight in kilograms divided by the square of the height in meters) of 40 or higher,
  • Receipt of positive pressure mechanical ventilation (invasive and non-invasive) within the 2 weeks preceding surgery (excluding routine treatment for obstructive sleep apnea syndrome)
  • Severe chronic respiratory disease, as indicated by any of:
  • Baseline FEV1 < 20 ml/kg predicted body weight
  • Pre-existing chronic interstitial lung disease with chronic interstitial infiltration on chest X-ray
  • Documented chronic CO2 retention (PaCO2 > 50 mm Hg) and/or chronic hypoxaemia (PaO2<55 mmHg on FiO2 = 0.21)
  • Chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vascular disease resulting in severe exercise restriction (e.g., unable to climb stairs or perform household duties), secondary polycythaemia, severe pulmonary hypertension (mean PAP > 40 mmHg), or ventilator dependency
  • Requirement for urgent/emergent surgery
  • Progressive neuromuscular illness\* that will result in prolonged need for mechanical ventilation
  • Previous randomization in this trial
  • Consent refusal
  • Surgeon, anesthesiologist, intensivist refusal

Study Design

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Subjects randomized to the intervention group will receive a comprehensive perioperative mechanical ventilation strategy that includes a bundle of protective settings (use of PEEP, recruitment maneuvers and continuation of mechanical ventilation during CPB).

no intervention: Control Group

Subjects randomized to the control group will receive mechanical ventilation according to the current usual care.

Interventions

A comprehensive perioperative mechanical ventilation strategy

1) Intervention group.

  • Recruitment maneuvers (doubling the tidal volumes for 10 consecutive breaths) every 30min and after every time mechanical ventilation is stopped for surgical reasons, suctioning occurs or the breathing circuit is disconnected
  • Mechanical ventilation will be continued during CPB (PEEP 5 cm H2O, respiratory rate 8/min, Tidal Volume 6 ml/kg PBW, FiO2 21%
  • Avoidance of lung de-recruitment during patient's transfer (use of PEEP via PEEP valves, endotracheal tube clamps during disconnection from the breathing circuit)
  • Avoidance of disconnection from respiratory circuit during respiratory secretions suctioning (applying closed suction circuits)
  • For the remaining aspects the mechanical ventilation settings will be the same as in the control group.

Tidal volume 6ml/kg PBW PEEP 5cm H20 FiO2 to target SatO2 of 92-97% Discontinuation of mechanical ventilation during cardiopulmonary bypass

Primary outcome measure

  • Post-operative pulmonary complications [ Time Frame: for 7 days post operatively ]

Central Contacts and Locations

Central contacts

Matteo Parotto, MD, PhD

416-340-4800matteo.parotto@uhn.ca

Locations

Toronto General Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Matteo Parotto, MD

416-340-4800matteo.parotto@uhn.ca

Jo Carroll

416-340-4800jo.carroll@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 30, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2021-04-30.