COMPARE-VENT Feasibility Pilot Study (NCT07656259) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
COMPARE-VENT Feasibility Pilot Study
United States75 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a feasibility pilot study and not yet recruiting, what does that mean for how much is already known about the safety and effectiveness of the ventilation approaches being compared, and would that affect your recommendation for me?
2This trial is specifically for people on mechanical ventilation with conditions like cardiogenic shock or cardiogenic pulmonary oedema — given my specific diagnosis, do you think I would even be a candidate to discuss when recruiting begins?
3The study is measuring how quickly patients can be started on the assigned ventilation mode after enrollment — does that kind of time pressure create any concerns for my situation, or would my care otherwise unfold at the same pace?
4Because this is a feasibility study focused on whether the trial design works rather than proving which ventilation method is better, what would I actually gain or risk by participating compared to just receiving standard ventilation care from your team?
5If I'm too unstable or my condition changes quickly, is there a point at which I or my family could withdraw from the assigned ventilation mode and switch to whatever you think is best clinically?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherance to assigned study mode (Feasibility Outcome)
Timeframe: Enrollment to 48 hours
2
Time From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome)