About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Volume Controlled Mode
  • Pressure Controlled Mode

Treatment groups

75 Participants
are divided into 2 treatment groups

Locations

1
Mayo Clinic, 1216 Second Street SW55905, RochesterMinnesota, United States

Sponsors and collaborators

Mayo Clinic

Lead sponsor