COMPARE-VENT Feasibility Pilot Study

NCT07656259 — Not applicable, Recruiting, 75 participants, Mayo Clinic

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COMPARE-VENT Feasibility Pilot Study: A Pragmatic Cluster Randomized Crossover Trial for Ventilation Strategies and Hemodynamic Impact in Critically Ill Patients With Cardiovascular Disease

RegistryNCT07656259
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, treatment
Enrollment75 (Estimated)
SponsorMayo Clinic (Other)
ConditionsRespiration Failure, Cardio Vascular Disease, Cardiogenic Pulmonary Oedema, Critical Illness, Mechanical Ventilation, Cardiogenic Shock, Cardiopulmonary
InterventionsVolume Controlled Mode, Pressure Controlled Mode (Other)
Datesstart 2026-07-01, primary completion 2027-02-28 (estimated), completion 2027-06-30 (estimated), first posted 2026-06-18, last updated 2026-08-10
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Respiration Failure All trials for Cardio Vascular Disease All trials of Volume Controlled Mode All trials of Pressure Controlled Mode

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Pressure Controlled VentilationActive comparatorOther: Pressure Controlled ModeDuring invasive mechanical ventilation in the cardiac ICU, pressure-controlled ventilation will be used as the mode for continuous mandatory ventilation.
Volume-Controlled VentilationActive comparatorOther: Volume Controlled ModeDuring invasive mechanical ventilation in the cardiac ICU, volume-controlled ventilation will be used as the mode for continuous mandatory ventilation.
  • Volume Controlled Mode (Other): Volume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume.
  • Pressure Controlled Mode (Other): Pressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Mayo Clinic, 1216 Second Street SWRochester, MinnesotaUnited StatesRecruiting

+Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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