COMPARE-VENT Feasibility Pilot Study

NCT07656259 | Recruiting

• 1 other identifier: 26-001781
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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; Cardiogenic Shock; Cardiopulmonary

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Enrollment to 48 Hours

Secondary Outcomes (8)

• In-hospital Mortality (Exploratory Clinical Outcome)

  Enrollment to Study Day 28

• Ventilator-Free Days (Exploratory Clinical Outcome)

  Enrollment to Study Day 28

• Organ Failure Free Survival Days (Exploratory Clinical Outcome)

  Enrollment to Study Day 28

• Vasoactive-inotrope score (Exploratory Hemodynamic Outcome)

  Enrollment to 48 hours

• Intensive Care Unit Length of Stay (Exploratory Clinical Outcome)

  Enrollment to Study Day 28

Study Arms (2)

Pressure Controlled Ventilation

ACTIVE COMPARATOR

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

Volume-Controlled Ventilation

ACTIVE COMPARATOR

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

Interventions

Volume Controlled Mode OTHER

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

Volume-Controlled Ventilation

Pressure Controlled Mode OTHER

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

Pressure Controlled Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• SCAI Stages C-E Cardiogenic Shock
• Mechanical circulatory support use, including intra-aortic balloon pumps and microaxial flow pumps, including Impella CP, RP Impella Flex, and Impella 5.5 devices
• Heart failure with reduced ejection fraction: LVEF \<40% or;
• Moderate to severe RV systolic dysfunction or;
• Moderate to severe Pulmonary hypertension, as defined by ACC/AHA/ESC guidelines

You may not qualify if:

• Expected duration of intubation \<12 hours.
• Severe COPD, bronchopleural fistulas, or severe ARDS (Berlin criteria P/F \<100, in the absence of pulmonary edema)
• Home ventilator or chronic tracheostomy.
• Pregnant, incarcerated, patients or those receiving extracorporeal membrane oxygenation

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic, 1216 Second Street SW

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (7)

• Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Muhs AL, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan TL, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, DeCoursey BR, Marvi TK, DeMasi SC, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Trial. medRxiv [Preprint]. 2024 Oct 9:2024.10.08.24314961. doi: 10.1101/2024.10.08.24314961.

  PMID: 39417127 BACKGROUND

• Zhou Y, Holets SR, Li M, Cortes-Puentes GA, Meyer TJ, Hanson AC, Schulte PJ, Oeckler RA. Etiology, incidence, and outcomes of patient-ventilator asynchrony in critically-ill patients undergoing invasive mechanical ventilation. Sci Rep. 2021 Jun 11;11(1):12390. doi: 10.1038/s41598-021-90013-z.

  PMID: 34117278 BACKGROUND

• Al Shehri AM, El-Tahan MR, Al Metwally R, Qutub H, El Ghoneimy YF, Regal MA, Zien H. Right ventricular function during one-lung ventilation: effects of pressure-controlled and volume-controlled ventilation. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):880-4. doi: 10.1053/j.jvca.2013.09.012. Epub 2014 Jan 18.

  PMID: 24447503 BACKGROUND

• Kim KN, Kim DW, Jeong MA, Sin YH, Lee SK. Comparison of pressure-controlled ventilation with volume-controlled ventilation during one-lung ventilation: a systematic review and meta-analysis. BMC Anesthesiol. 2016 Aug 31;16(1):72. doi: 10.1186/s12871-016-0238-6.

  PMID: 27581657 BACKGROUND

• Li XF, Mao WJ, Jiang RJ, Yu H, Zhang MQ, Yu H. Effect of Mechanical Ventilation Mode Type on Postoperative Pulmonary Complications After Cardiac Surgery: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Feb;38(2):437-444. doi: 10.1053/j.jvca.2023.11.024. Epub 2023 Nov 19.

  PMID: 38105126 BACKGROUND

• Rittayamai N, Katsios CM, Beloncle F, Friedrich JO, Mancebo J, Brochard L. Pressure-Controlled vs Volume-Controlled Ventilation in Acute Respiratory Failure: A Physiology-Based Narrative and Systematic Review. Chest. 2015 Aug;148(2):340-355. doi: 10.1378/chest.14-3169.

  PMID: 25927671 BACKGROUND

• Alviar CL, Miller PE, McAreavey D, Katz JN, Lee B, Moriyama B, Soble J, van Diepen S, Solomon MA, Morrow DA; ACC Critical Care Cardiology Working Group. Positive Pressure Ventilation in the Cardiac Intensive Care Unit. J Am Coll Cardiol. 2018 Sep 25;72(13):1532-1553. doi: 10.1016/j.jacc.2018.06.074.

  PMID: 30236315 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Critical Illness; Shock, Cardiogenic; Cardiovascular Diseases; Heart Arrest

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)