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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07656259
- Acronym / sponsor ID
- 26-001781
- Conditions
- Respiration Failure, Cardio Vascular Disease, Cardiogenic Pulmonary Oedema, Critical Illness, Mechanical Ventilation, Cardiogenic Shock
- Keywords
- Cardiovascular disease, Cardiac arrest, Cardiogenic shock, Respiratory failure, Cardiopulmonary interactions, Critical illness, Intensive care unit, Critical care therapies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure Controlled Ventilation | Active comparator | Other: 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 Ventilation | Active comparator | Other: Volume Controlled ModeDuring invasive mechanical ventilation in the cardiac ICU, volume-controlled ventilation will be used as the mode for continuous mandatory ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible adults ≥ 18 years of age admitted to the cardiac ICU with need for invasive mechanical ventilation of expected duration >12 hours.
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume Controlled ModeVolume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume. | Other | Volume-Controlled Ventilation |
| Pressure Controlled ModePressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure. | Other | Pressure Controlled Ventilation |
Primary outcome
Adherance to assigned study mode (Feasibility Outcome)
Time frame: 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)
Time frame: 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 39417127Seitz 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.
- Background: PubMed 34117278Zhou 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.
- Background: PubMed 24447503Al 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.
- Background: PubMed 27581657Kim 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.
- Background: PubMed 38105126Li 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.
- Background: PubMed 25927671Rittayamai 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.
- Background: PubMed 30236315Alviar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Respiration Failure and Cardio Vascular Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherance to assigned study mode (Feasibility Outcome) (time frame: Enrollment to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07656259, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.