Status:
UNKNOWN
Protective Mechanical VENTilation Strategy in Patients Undergoing CARDiac Surgery
Lead Sponsor:
University Health Network, Toronto
Conditions:
Pulmonary Complications
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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 y...
Detailed Description
Postoperative pulmonary complications are frequent after cardiac surgery, affecting approximately 30% of all patients. Such complications result in increased morbidity, mortality and health care utili...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT03288558
Start Date
July 7 2017
End Date
April 1 2022
Last Update
April 30 2021
Active Locations (1)
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1
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4