What this study is
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.
What's being tested
- Volume Controlled Mode
Intervention · OTHER
Volume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume.
- Pressure Controlled Mode
Intervention · OTHER
Pressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure.
Study details
- Official title
- COMPARE-VENT Feasibility Pilot Study: A Pragmatic Cluster Randomized Crossover Trial for Ventilation Strategies and Hemodynamic Impact in Critically Ill Patients With Cardiovascular Disease
- Sponsor
- Mayo Clinic
- Conditions
- Respiration Failure · Cardio Vascular Disease · Cardiogenic Pulmonary Oedema · Critical Illness · Mechanical Ventilation · Cardiogenic Shock · Cardiopulmonary
- Enrolling
- 75 people
- Starts
- 2026-07-01
- Est. completion
- 2027-06-30
- Design
- Open-label, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic, 1216 Second Street SW
Rochester, Minnesota, United States
- Garima Dahiya · Contact507-255-1051dahiya.garima@mayo.edu
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 26-001781
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.