COMPARE-VENT Feasibility Pilot Study
Recruiting · NCT07656259 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Mayo Clinic, 1216 Second Street SW - Rochester, Minnesota, United States