Cardiac Surgery Clinical Trial
Official title:
Protective Mechanical VENTilation Strategy in Patients Undergoing CARDiac Surgery (VENT CARD Trial)
NCT number | NCT03288558 |
Other study ID # | 17-5171 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 7, 2017 |
Est. completion date | April 1, 2022 |
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.
Status | Recruiting |
Enrollment | 310 |
Est. completion date | April 1, 2022 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital, University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative pulmonary complications | Daily chart review and assessment of any pulmonary complications documented | for 7 days post operatively | |
Secondary | Ventilator free days | number of days without a ventilator
Number of days without ventilation |
Post op day 1-28 days | |
Secondary | Intensive care length of stay | Number of days in the intensive care unit | Post op day 1-28 days | |
Secondary | Hospital length of stay | Number of days in the hospital | Post op day 1-28 days | |
Secondary | Duration of mechanical ventilation | Length of time on a ventilator | Post op day 1-28 days | |
Secondary | Ease of surgical access | Ability of the surgeon to access the surgical field during cardiopulmonary bypass using a 5 point Likert scale | Intraoperatively during surgery | |
Secondary | Barotrauma | defined as radiological evidence of pneumothorax and/or pneumomediastinum | in the first 7 days after surgery | |
Secondary | Surgical complications | death, myocardial infarction, stroke, acute liver injury, and chest reopening | From the day of surgery to 48 hours post surgery | |
Secondary | Acute Kidney Injury | Incidence of Acute Kidney Injury across the study population | Day of surgery to 28 days | |
Secondary | Mortality | Incidence of mortality across the study population | Day of surgery to 90-day | |
Secondary | Home and alive | to evaluate days at home | up to 30 days after surgery |
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