Protective Mechanical VENTilation Strategy in Patients Undergoing CARDiac Surgery

NCT03288558 | Unknown DMC

• 1 other identifier: 17-5171
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Post-operative pulmonary complications

  Daily chart review and assessment of any pulmonary complications documented

  for 7 days post operatively

Secondary Outcomes (10)

• Ventilator free days

  Post op day 1-28 days

• Intensive care length of stay

  Post op day 1-28 days

• Hospital length of stay

  Post op day 1-28 days

• Duration of mechanical ventilation

  Post op day 1-28 days

• Ease of surgical access

  Intraoperatively during surgery

Study Arms (2)

Intervention Group

EXPERIMENTAL

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).

Other: A comprehensive perioperative mechanical ventilation strategy

Control Group

NO INTERVENTION

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

Interventions

A comprehensive perioperative mechanical ventilation strategy OTHER

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

Intervention 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Study Officials

• Matteo Parotto, MD, PhD

  Toronto General Hospital, UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Parotto, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager Anesthesia Research

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 20, 2017
• Study Start: July 7, 2017
• Primary Completion: December 30, 2021
• Study Completion: April 1, 2022
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)