COMPARE-VENT Feasibility Pilot Study

Official title

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

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.

Interventions

• Other Volume Controlled Mode
  Volume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume.
• Other Pressure Controlled Mode
  Pressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure.

Primary outcome measures

• 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]

Secondary outcome measures (8)

• In-hospital Mortality (Exploratory Clinical Outcome) [Time frame: Enrollment to Study Day 28]
• Ventilator-Free Days (Exploratory Clinical Outcome) [Time frame: Enrollment to Study Day 28]
• Organ Failure Free Survival Days (Exploratory Clinical Outcome) [Time frame: Enrollment to Study Day 28]
• Vasoactive-inotrope score (Exploratory Hemodynamic Outcome) [Time frame: Enrollment to 48 hours]
• Intensive Care Unit Length of Stay (Exploratory Clinical Outcome) [Time frame: Enrollment to Study Day 28]
• Patient Ventilator Dyssynchrony Events [Time frame: Enrollment to 48 hours]
• Exhaled Tidal Volume (mL/kg Predicted Body Weight) (Exploratory Ventilatory Outcome) [Time frame: Enrollment to 48 hours]
• Median RASS Score (Exploratory Safety Outcome) [Time frame: Enrollment to 48 hours]

Eligibility criteria

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:

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Mayo Clinic, 1216 Second Street SW — Rochester

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 Criti 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

Identifiers

NCT: NCT07656259 · 26-001781

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗