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NCT Number: NCT07656259

COMPARE-VENT Feasibility Pilot 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.

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Key information

Conditions

Respiration Failure Cardio Vascular Disease Cardiogenic Pulmonary Oedema Cardiogenic Shock Cardiopulmonary Cardiovascular Diseases Critical Illness Disease Attributes Heart Arrest Heart Diseases Infarction Ischemia Mechanical Ventilation Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, 1216 Second Street SW

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Garima Dahiya

CONTACT

[email protected]

507-255-1051

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volume Controlled Mode

Other

Volume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume.

Pressure Controlled Mode

Other

Pressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure.

Primary outcomes

  1. Adherance to assigned study mode (Feasibility Outcome)

    Time frame: Enrollment to 48 hours

    Percentage of time spent on the assigned study mode while receiving invasive mechanical ventilation in the cardiac ICU between enrollment and 48 hours after enrollment.

  2. Time From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome)

    Time frame: Enrollment to 48 Hours

    Time (number of hours) taken to initiate participants from enrollment (cardiac ICU admission) to initiation of assigned study mode of invasive mechanical ventilation upto 48 hours after enrollment.

Secondary outcomes

  1. In-hospital Mortality (Exploratory Clinical Outcome)

    Time frame: Enrollment to Study Day 28

    All-cause, 28-day, in-hospital mortality, defined as death from any cause occurring between enrollment and 28 days after enrollment.

  2. Ventilator-Free Days (Exploratory Clinical Outcome)

    Time frame: Enrollment to Study Day 28

    The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation.

  3. Organ Failure Free Survival Days (Exploratory Clinical Outcome)

    Time frame: Enrollment to Study Day 28

    The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation, renal replacement therapy, mechanical circulatory and vasoactive medication support.

  4. Vasoactive-inotrope score (Exploratory Hemodynamic Outcome)

    Time frame: Enrollment to 48 hours

    The Vasoactive-Inotropic Score (VIS) is a quantitative measure of the total cardiovascular support a patient receives through vasopressors and inotropes, by a standardized conversion to per-kilogram per-minute units. Higher VIS indicates greater dependence on pharmacologic support and is associated with worse outcomes.

  5. Intensive Care Unit Length of Stay (Exploratory Clinical Outcome)

    Time frame: Enrollment to Study Day 28

    Number of days between enrollment and 28 days after enrollment, on which the patient is alive and free from intensive care unit admission after the final transfer out of the intensive care unit

  6. Patient Ventilator Dyssynchrony Events

    Time frame: Enrollment to 48 hours

    Number of participants with flow, trigger or cycle dyssynchrony during assigned study mode for invasive mechanical ventilation.

  7. Exhaled Tidal Volume (mL/kg Predicted Body Weight) (Exploratory Ventilatory Outcome)

    Time frame: Enrollment to 48 hours

    Measured in mL/kg of predicted body weight

  8. Median RASS Score (Exploratory Safety Outcome)

    Time frame: Enrollment to 48 hours

    RASS is a 10-point scale of agitation or sedation ranging from -5 (most sedated, comatose) to +4 (most agitated, combative). The sedation requirement for each ventilator mode will be assessed via RASS score.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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