Ventilation Modes for Respiratory Failure in Cardiovascular Disease
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for adults (18+) in the cardiac ICU who need a breathing machine (ventilator) for more than 12 hours due to serious heart and lung problems, such as cardiogenic shock or severe heart failure. People with certain lung diseases, short-term ventilation needs, home ventilators, pregnancy, incarceration, or on ECMO can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either pressure-controlled or volume-controlled ventilation in the cardiac ICU
Follow-up
Participants are monitored for safety and effectiveness after treatment, including in-hospital mortality and ventilator-free days
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two common ways of using a ventilator—volume-controlled mode versus pressure-controlled mode—in critically ill heart patients. Patients are assigned by groups to each method to see which works better and is easier to use in real-world settings.
How Is the Trial Designed?
2
Treatment groups
Active Control
During invasive mechanical ventilation in the cardiac ICU, pressure-controlled ventilation will be used as the mode for continuous mandatory ventilation.
During invasive mechanical ventilation in the cardiac ICU, volume-controlled ventilation will be used as the mode for continuous mandatory ventilation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
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