Cardiogenic Pulmonary Oedema, Cardiogenic Shock, Cardiopulmonary, Cardio Vascular Disease, Critical Illness, Mechanical Ventilation, Respiration Failure
Conditions
Keywords
Cardiovascular disease, Cardiac arrest, Cardiogenic shock, Respiratory failure, Cardiopulmonary interactions, Critical illness, Intensive care unit, Critical care therapies, Outcomes, Mechanical ventilation, Positive pressure ventilation
Brief 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.
Interventions
OTHERVolume Controlled Mode
Volume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume.
OTHERPressure Controlled Mode
Pressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherance to assigned study mode (Feasibility Outcome) | Enrollment to 48 hours | 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 From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome) | Enrollment to 48 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Mortality (Exploratory Clinical Outcome) | Enrollment to Study Day 28 | All-cause, 28-day, in-hospital mortality, defined as death from any cause occurring between enrollment and 28 days after enrollment. |
| Ventilator-Free Days (Exploratory Clinical Outcome) | Enrollment to Study Day 28 | The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation. |
| Organ Failure Free Survival Days (Exploratory Clinical Outcome) | Enrollment to Study Day 28 | 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. |
| Vasoactive-inotrope score (Exploratory Hemodynamic Outcome) | Enrollment to 48 hours | 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. |
| Intensive Care Unit Length of Stay (Exploratory Clinical Outcome) | Enrollment to Study Day 28 | 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 |
| Patient Ventilator Dyssynchrony Events | Enrollment to 48 hours | Number of participants with flow, trigger or cycle dyssynchrony during assigned study mode for invasive mechanical ventilation. |
| Exhaled Tidal Volume (mL/kg Predicted Body Weight) (Exploratory Ventilatory Outcome) | Enrollment to 48 hours | Measured in mL/kg of predicted body weight |
| Median RASS Score (Exploratory Safety Outcome) | Enrollment to 48 hours | 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. |
Countries
United States
Outcome results
None listed