COMPARE-VENT Feasibility Pilot Study

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07656259
Status
Not Yet Recruiting

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Conditions

  • Cardio Vascular Disease
  • Cardiogenic Pulmonary Oedema
  • Cardiogenic Shock
  • Cardiopulmonary
  • Critical Illness
  • Mechanical Ventilation
  • Respiration Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pressure Controlled Ventilation
    During invasive mechanical ventilation in the cardiac ICU, pressure-controlled ventilation will be used as the mode for continuous mandatory ventilation.
  • Active Comparator: Volume-Controlled Ventilation
    During invasive mechanical ventilation in the cardiac ICU, volume-controlled ventilation will be used as the mode for continuous mandatory ventilation.

Primary Outcome Measure

Adherance to assigned study mode (Feasibility Outcome) [ Time Frame: Enrollment to 48 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic, 1216 Second Street SWRochesterMinnesota55905
Garima Dahiya
[email protected]
507-255-1051

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By research site
Mayo Clinic, 1216 Second Street SW· Rochester, MN

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