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COMPARE-VENT Feasibility Pilot Study

RecruitingNAAges 18 Years - anyAllMayo Clinic
NCT07656259 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 wit

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📋 Eligibility rules (as published)
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
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What it tests

  • Volume Controlled Mode
  • Pressure Controlled Mode
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Where

1 site
Mayo Clinic, 1216 Second Street SW
Rochester, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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