Recruiting

Ventilatory Modes

Sponsor:

Mayo Clinic

Code:

NCT07656259

Conditions

Respiration Failure

Cardio Vascular Disease

Cardiogenic Pulmonary Oedema

Critical Illness

Mechanical Ventilation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Volume Controlled Mode

Pressure Controlled Mode

Study Details

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.

Conditions

Respiration Failure

Cardio Vascular Disease

Cardiogenic Pulmonary Oedema

Critical Illness

Mechanical Ventilation

Study ID

NCT07656259

Start date

Jul 1, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Volume Controlled Mode

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

Pressure Controlled Mode

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

Primary outcome measure

  • Adherance to assigned study mode (Feasibility Outcome) [ Time Frame: Enrollment to 48 hours ]
  • Time From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome) [ Time Frame: Enrollment to 48 Hours ]

Central Contacts and Locations

Locations

Mayo Clinic, 1216 Second Street SW

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Garima Dahiya

507-255-1051dahiya.garima@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-10.