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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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: 1. SCAI Stages C-E Cardiogenic Shock 2. Mechanical circulatory support use, including intra-aortic balloon pumps and microaxial flow pumps, including Impella CP, RP Impella Flex, and Impella 5.5 devices 3. Heart failure with reduced ejection fraction: LVEF \<40% or; 4. Moderate to severe RV systolic dysfunction or; 5. Moderate to severe Pulmonary hypertension, as defined by ACC/AHA/ESC guidelines Exclusion Criteria: 1. Expected duration of intubation \<12 hours. 2. Severe COPD, bronchopleural fistulas, or severe ARDS (Berlin criteria P/F \<100, in the absence of pulmonary edema) 3. Home ventilator or chronic tracheostomy. 4. Pregnant, incarcerated, patients or those receiving extracorporeal membrane oxygenation

Study sites (1)

MN