Compare two ventilator modes in adults with cardiac ICU needs and invasive ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility pilot investigates two ventilation strategies—volume-controlled and pressure-controlled modes—in adults admitted to a cardiac ICU who require invasive mechanical ventilation for more than 12 hours. The study aims to assess feasibility and gather exploratory data on how these modes affect patient-ventilator interaction, sedation needs, and hemodynamics in the setting of cardiogenic disease and varying degrees of heart failure or shock. Participants may belong to predefined subgroups such as cardiogenic shock stages, use of mechanical circulatory support, reduced ejection fraction, right ventricular dysfunction, or pulmonary hypertension. The trial is led by Mayo Clinic and conducted at the Mayo Clinic in Rochester, Minnesota, without listed collaborators. Outcomes will inform whether a larger, definitive comparison is warranted in this high-risk population.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic, 1216 Second Street SW
  Rochester, Minnesota, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.