COMPARE-VENT Feasibility Pilot Study

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: Pressure Controlled Mode
    Pressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure.
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.
  • Other: Volume Controlled Mode
    Volume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume.

Recruiting Locations

Mayo Clinic, 1216 Second Street SW
Rochester, Minnesota 55905
Contact:
Garima Dahiya
507-255-1051
dahiya.garima@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact