New device aims to wean ventilator patients faster
NCT ID NCT06832306
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The places running it
7 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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Louisiana State University Health Sciences
RECRUITINGShreveport, Louisiana, 71103, United States
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Prisma Health
RECRUITINGColumbia, South Carolina, 29203, United States
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Temple University
RECRUITINGPhiladelphia, Pennsylvania, 19122, United States
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University Health Network (UHN)
RECRUITINGToronto, Ontario, M5G 2C4, Canada
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University of California San Diego
RECRUITINGLa Jolla, California, 92037, United States
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Wake Forest University School of Medicine
ENROLLING_BY_INVITATIONWinston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Steroid dose showdown: can more dexamethasone save lives in respiratory failure?
- Could letting patients breathe on their own sooner protect their lungs?
- Scientists hunt for hidden subgroups in sudden respiratory failure
- Can a smart oxygen device outperform manual care in recovery?
- Low oxygen or organ failure? study aims to uncover true driver of ICU deaths
- AI could predict which ICU patients with breathing failure are at highest risk of death