COMPARE-VENT Feasibility Pilot Study

NCT07656259 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-08-10

No results posted yet for this study

Summary

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

Interventions

OTHER

Volume Controlled Mode

Volume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume.

OTHER

Pressure Controlled Mode

Pressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-02-28
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07656259 on ClinicalTrials.gov