An interventional study of A comprehensive perioperative mechanical ventilation strategy in Pulmonary Complications and Cardiac Surgery, sponsored by University Health Network, Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Prevention
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.
Postoperative pulmonary complications are frequent after cardiac surgery, affecting approximately 30% of all patients. Such complications result in increased morbidity, mortality and health care utilization. During and immediately after surgery, mechanical ventilation is required to control the patient's breathing. Recent scientific literature showed the striking importance of specific mechanical ventilation settings (which often constituted a bundle of interventions and were generally called "protective mechanical ventilation") in other areas of medicine (i.e., critical care, abdominal surgery, management of organ donors) to prevent the onset or propagation of lung injury as well as multiple organ dysfunction. These protective settings include tidal volume of 6 ml/kg of ideal body weight (as opposed to the traditional tidal volume of 10-12 ml/kg), use of positive end expiratory pressure (PEEP), recruitment maneuvers (temporary periodic application of higher respiratory pressures or volumes on the mechanical ventilator in order to re-open collapsed areas of the lungs) and attention at avoiding lung collapse during patient transfer and suctioning (i.e. maintaining PEEP during transfer and avoiding disconnection from the breathing circuit during suctioning of respiratory secretions). Such interventions could play an even more important role during cardiac surgery, where several insults to the lung take place. These insults result from the inflammatory cascade triggered by cardiopulmonary bypass (CPB), myocardial injury and areas of lung collapse (atelectasis). Indeed, a recent retrospective study showed that the tidal volume utilized during and after cardiac surgery impacts significantly on organ dysfunction, with a tidal volume less than 10 ml/kg of ideal body weight providing better outcomes than larger tidal volumes.
The investigators hypothesize that our proposed bundle of protective mechanical ventilation settings aimed at minimizing lung injury by continuation of mechanical ventilation during cardiopulmonary bypass, recruitment maneuvers, and use of systems that prevent lung collapse during patient transfer and suctioning (i.e. PEEP valves and closed respiratory circuits) will reduce postoperative pulmonary complications compared to the current standard of care, hence significantly improving patients outcomes and reducing health care costs.
Exclusion Criteria:
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
Subjects randomized to the control group will receive mechanical ventilation according to the current usual care.
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
Post-operative pulmonary complications
Daily chart review and assessment of any pulmonary complications documented
Time frame: for 7 days post operatively
Ventilator free days
number of days without a ventilator Number of days without ventilation
Time frame: Post op day 1-28 days
Intensive care length of stay
Number of days in the intensive care unit
Time frame: Post op day 1-28 days
Hospital length of stay
Number of days in the hospital
Time frame: Post op day 1-28 days
Duration of mechanical ventilation
Length of time on a ventilator
Time frame: Post op day 1-28 days
Ease of surgical access
Ability of the surgeon to access the surgical field during cardiopulmonary bypass using a 5 point Likert scale
Time frame: Intraoperatively during surgery
Barotrauma
defined as radiological evidence of pneumothorax and/or pneumomediastinum
Time frame: in the first 7 days after surgery
Surgical complications
death, myocardial infarction, stroke, acute liver injury, and chest reopening
Time frame: From the day of surgery to 48 hours post surgery
Acute Kidney Injury
Incidence of Acute Kidney Injury across the study population
Time frame: Day of surgery to 28 days
Mortality
Incidence of mortality across the study population
Time frame: Day of surgery to 90-day
Home and alive
to evaluate days at home
Time frame: up to 30 days after surgery
Plan to share: No
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University Health Network, Toronto