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New device aims to wean ventilator patients faster

NCT ID NCT06832306

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Updated 4 times

Summary

This study tests a temporary device that stimulates the diaphragm (the main breathing muscle) in ICU patients on breathing machines. The goal is to see if it helps patients breathe more on their own and recover from lung injury. About 30 adults with severe breathing failure will be randomly assigned to get the device plus standard care or standard care alone.

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 30 people

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

Started

May 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Male or female, 18 years or older, and 2. Able to provide informed consent or have a legally authorized representative (LAR) / Substitute Decision Maker (SDM) who can provide consent, and 3. Have acute onset of new respiratory symptoms or dysfunction within the 2 weeks before onset of need for respiratory support, and 4. Have arterial hypoxemia defined by one of: * PaO2:FiO2 ratio ≤300 mm Hg on PEEP ≥5 cm H2O, or * In the absence of an available arterial blood gas, SpO2 ≤97% on FiO2 ≥0.5 and PEEP ≥5 cm H2O with reliable SpO2 trace for the 2 hours immediately preceding eligibility assessment (this correlates to an upper limit of SpO2:FiO2 ratio of 316%) or * Are receiving pulmonary vasodilators for acute hypoxemia, or * Are being ventilated in the prone position for acute hypoxemia, and 5. Have been mechanically ventilated for AHRF in the ICU for \<96 hours at the time of enrolment, and 6. Are expected to require invasive mechanical ventilation ≥48 hours after enrollment in the opinion of the treating clinician Exclusion Criteria: 1. Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism. 2. Underlying chronic parenchymal lung disease that may make recovery/extubation a challenge (e.g., COPD, pulmonary fibrosis). 3. Broncho-pleural fistula at the time of eligibility assessment. 4. Require extracorporeal membrane oxygenation. 5. Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles. 6. BMI \>70 kg/m2. 7. Contraindications to left internal jugular vein or left subclavian vein catheterization (e.g., infection at the access site, known central venous stenosis, septic thrombophlebitis, left internal jugular ECMO cannula in situ, poor target vessels). 8. Patient expected to transition to fully palliative care within 72 hours of enrollment. 9. Chronic severe liver disease (e.g., Child-Pugh Score ≥10) 10. Treating clinician deems enrollment not clinically appropriate. 11. Currently enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study. 12. Any electrical device (implanted or external) that may be prone to interaction with or interference from the AeroNova System, including neurological pacing/stimulator devices and cardiac pacemakers and defibrillators. 13. Known or suspected to be pregnant or lactating.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    7 sites in 2 countries. 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

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Louisiana State University Health Sciences

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Prisma Health

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Temple University

    RECRUITING

    Philadelphia, Pennsylvania, 19122, United States

  • University Health Network (UHN)

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92037, United States

  • Wake Forest University School of Medicine

    ENROLLING_BY_INVITATION

    Winston-Salem, North Carolina, 27157, United States

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