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Which ventilator mode is best for heart patients? a pilot study aims to find out

NCT ID NCT07656259

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 4 times

Summary

This study tests whether it is possible to run a larger trial comparing two ways of using a breathing machine (ventilator) in critically ill heart patients who need help breathing. The two modes are volume-controlled (delivers a set amount of air each breath) and pressure-controlled (delivers air at a set pressure). The study includes adults in the cardiac ICU expected to need a ventilator for more than 12 hours. The main goal is to see how well doctors can stick to the assigned mode and how quickly it starts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mechanical ventilation modes (volume-controlled vs. pressure-controlled)
What this could lead to
If feasible, this could pave the way for a larger trial to determine which ventilation mode is safer for patients with heart problems.
What could go wrong
This is a small pilot study focused on feasibility, not on proving which mode is better. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiac arrest cardiogenic shock cardiovascular disorder Critical Illness pulmonary edema pulmonary hypertension respiratory failure Shock, Cardiogenic systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardio vascular disease Cardiogenic pulmonary oedema Cardiogenic shock Cardiopulmonary Critical illness Mechanical ventilation Respiration failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic, 1216 Second Street SW

    RECRUITING

    Rochester, Minnesota, 55905, United States

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