NCT07656259Recruiting
COMPARE-VENT Feasibility Pilot Study
COMPARE-VENT Feasibility Pilot Study: A Pragmatic Cluster Randomized Crossover Trial for Ventilation Strategies and Hemodynamic Impact in Critically Ill Patients With Cardiovascular Disease
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Mayo Clinic
- Diseases
- Heart failure
- NCT number
- NCT07656259
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 1 Jul 2026 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant, incarcerated, patients or those receiving extracorporeal membrane oxygenation
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic, 1216 Second Street SW Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.