COMPARE-VENT Feasibility Pilot Study

Mayo Clinic75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiration Failure Cardio Vascular Disease

Interventions

Volume Controlled ModeOTHER

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

Pressure Controlled ModeOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adherance to assigned study mode (Feasibility Outcome)

Percentage of time spent on the assigned study mode while receiving invasive mechanical ventilation in the cardiac ICU between enrollment and 48 hours after enrollment.

Time frame: Enrollment to 48 hours

Time From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome)

Time (number of hours) taken to initiate participants from enrollment (cardiac ICU admission) to initiation of assigned study mode of invasive mechanical ventilation upto 48 hours after enrollment.

Time frame: Enrollment to 48 Hours

Secondary Outcomes

In-hospital Mortality (Exploratory Clinical Outcome)

All-cause, 28-day, in-hospital mortality, defined as death from any cause occurring between enrollment and 28 days after enrollment.

Time frame: Enrollment to Study Day 28

Ventilator-Free Days (Exploratory Clinical Outcome)

The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation.

Time frame: Enrollment to Study Day 28

Organ Failure Free Survival Days (Exploratory Clinical Outcome)

The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation, renal replacement therapy, mechanical circulatory and vasoactive medication support.

Time frame: Enrollment to Study Day 28

Vasoactive-inotrope score (Exploratory Hemodynamic Outcome)

The Vasoactive-Inotropic Score (VIS) is a quantitative measure of the total cardiovascular support a patient receives through vasopressors and inotropes, by a standardized conversion to per-kilogram per-minute units. Higher VIS indicates greater dependence on pharmacologic support and is associated with worse outcomes.

Time frame: Enrollment to 48 hours

Intensive Care Unit Length of Stay (Exploratory Clinical Outcome)

Number of days between enrollment and 28 days after enrollment, on which the patient is alive and free from intensive care unit admission after the final transfer out of the intensive care unit

Time frame: Enrollment to Study Day 28

Patient Ventilator Dyssynchrony Events

Number of participants with flow, trigger or cycle dyssynchrony during assigned study mode for invasive mechanical ventilation.

Time frame: Enrollment to 48 hours

Exhaled Tidal Volume (mL/kg Predicted Body Weight) (Exploratory Ventilatory Outcome)

Measured in mL/kg of predicted body weight

Time frame: Enrollment to 48 hours

Median RASS Score (Exploratory Safety Outcome)

RASS is a 10-point scale of agitation or sedation ranging from -5 (most sedated, comatose) to +4 (most agitated, combative). The sedation requirement for each ventilator mode will be assessed via RASS score.

Time frame: Enrollment to 48 hours

COMPARE-VENT Feasibility Pilot Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes