COMPARE-VENT Feasibility Pilot Study: A Pragmatic Cluster Randomized Crossover Trial for Ventilation Strategies and Hemodynamic Impact in Critically Ill Patients With Cardiovascular Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Adherance to assigned study mode (Feasibility Outcome)
Study Overview
Brief Summary
Cardiac disease complicated by respiratory insufficiency comprises the most frequent indication for cardiac intensive care unit (CICU) admission, with nearly one-third patients requiring advanced respiratory support and over 20% patients requiring invasive mechanical ventilation (IMV). IMV among patients with impaired cardiovascular reserve is further compounded by the adverse impact of positive pressure ventilation (PPV) and systemic sedation on intracardiac hemodynamics, pulmonary vascular mechanics and consequently end-organ perfusion. Despite widespread use, evidence guiding optimal ventilatory practices and mode selection in cardiovascular intensive care unit patients remains limited. Pressure-controlled and volume-controlled ventilation may differ in their effects on patient-ventilator synchrony, sedation requirements, and hemodynamic impact, but comparative data among patients with critical cardiac disease remains inconclusive. This pilot study will evaluate the feasibility of implementing a pragmatic cluster-randomized crossover trial comparing ventilatory modes in a contemporary cardiovascular intensive care unit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible adults ≥ 18 years of age admitted to the cardiac ICU with need for invasive mechanical ventilation of expected duration >12 hours.
- •Pre-Specified Subgroups for exploratory outcomes:
- •SCAI Stages C-E Cardiogenic Shock
- •Mechanical circulatory support use, including intra-aortic balloon pumps and microaxial flow pumps, including Impella CP, RP Impella Flex, and Impella 5.5 devices
- •Heart failure with reduced ejection fraction: LVEF <40% or;
- •Moderate to severe RV systolic dysfunction or;
- •Moderate to severe Pulmonary hypertension, as defined by ACC/AHA/ESC guidelines
Exclusion Criteria
- •Expected duration of intubation <12 hours.
- •Severe COPD, bronchopleural fistulas, or severe ARDS (Berlin criteria P/F <100, in the absence of pulmonary edema)
- •Home ventilator or chronic tracheostomy.
- •Pregnant, incarcerated, patients or those receiving extracorporeal membrane oxygenation
Arms & Interventions
Pressure Controlled Ventilation
During invasive mechanical ventilation in the cardiac ICU, pressure-controlled ventilation will be used as the mode for continuous mandatory ventilation.
Intervention: Pressure Controlled Mode (Other)
Volume-Controlled Ventilation
During invasive mechanical ventilation in the cardiac ICU, volume-controlled ventilation will be used as the mode for continuous mandatory ventilation.
Intervention: Volume Controlled Mode (Other)
Outcomes
Primary Outcomes
Adherance to assigned study mode (Feasibility Outcome)
Time Frame: Enrollment to 48 hours
Percentage of time spent on the assigned study mode while receiving invasive mechanical ventilation in the cardiac ICU between enrollment and 48 hours after enrollment.
Time From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome)
Time Frame: Enrollment to 48 Hours
Time (number of hours) taken to initiate participants from enrollment (cardiac ICU admission) to initiation of assigned study mode of invasive mechanical ventilation upto 48 hours after enrollment.
Secondary Outcomes
- In-hospital Mortality (Exploratory Clinical Outcome)(Enrollment to Study Day 28)
- Ventilator-Free Days (Exploratory Clinical Outcome)(Enrollment to Study Day 28)
- Organ Failure Free Survival Days (Exploratory Clinical Outcome)(Enrollment to Study Day 28)
- Vasoactive-inotrope score (Exploratory Hemodynamic Outcome)(Enrollment to 48 hours)
- Intensive Care Unit Length of Stay (Exploratory Clinical Outcome)(Enrollment to Study Day 28)
- Patient Ventilator Dyssynchrony Events(Enrollment to 48 hours)
- Exhaled Tidal Volume (mL/kg Predicted Body Weight) (Exploratory Ventilatory Outcome)(Enrollment to 48 hours)
- Median RASS Score (Exploratory Safety Outcome)(Enrollment to 48 hours)
Investigators
Garima Dahiya
Assistant Professor of Medicine
Mayo Clinic