Respiration FailureNCT07656259
COMPARE-VENT Feasibility Pilot Study
A study of Respiration Failure and Cardio Vascular Disease, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration Failure, Cardio Vascular Disease, Cardiogenic Pulmonary Oedema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic, 1216 Second Street SW
Rochester, Minnesota, 55905
Garima Dahiya, 507-255-1051, dahiya.garima@mayo.edu
About this 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
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
- Being tested
- Volume Controlled Mode, Pressure Controlled Mode
- 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
- Medical subject headings
- Respiratory Insufficiency, Critical Illness, Shock, Cardiogenic, Cardiovascular Diseases, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume Controlled ModeOther
Volume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume.
Pressure Controlled ModeOther
Pressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Volume Controlled Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Enrollment to 48 Hours
Secondary outcomes (8)
In-hospital Mortality (Exploratory Clinical Outcome)
All-cause, 28-day, in-hospital mortality, defined as death from any cause occurring between enrollment and 28 days after enrollment.
Measured: Enrollment to Study Day 28
Ventilator-Free Days (Exploratory Clinical Outcome)
The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation.
Measured: Enrollment to Study Day 28
Organ Failure Free Survival Days (Exploratory Clinical Outcome)
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.
Measured: Enrollment to Study Day 28
Vasoactive-inotrope score (Exploratory Hemodynamic Outcome)
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.
Measured: Enrollment to 48 hours
Intensive Care Unit Length of Stay (Exploratory Clinical Outcome)
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
Measured: Enrollment to Study Day 28
Patient Ventilator Dyssynchrony Events
Number of participants with flow, trigger or cycle dyssynchrony during assigned study mode for invasive mechanical ventilation.
Measured: Enrollment to 48 hours
Exhaled Tidal Volume (mL/kg Predicted Body Weight) (Exploratory Ventilatory Outcome)
Measured in mL/kg of predicted body weight
Measured: Enrollment to 48 hours
Median RASS Score (Exploratory Safety Outcome)
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.
Measured: Enrollment to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Respiration FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garima Dahiya, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656259
- Sponsor's protocol ID
- 26-001781
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39417127Zhou 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.
PubMed 34117278Al 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.
PubMed 24447503Kim 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.
PubMed 27581657Li 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.
PubMed 38105126Rittayamai 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.
PubMed 25927671Alviar 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.
PubMed 30236315