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Can a tiny, No-Moving-Parts respirator replace ventilators in a crisis?

NCT ID NCT07768215

Disease control Sponsor: National Institutes of Health Clinical Center (CC) Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Sep 09, 2026 · Updated 16 times

Summary

This first-in-human pilot study tests an investigational miniature breathing device called the Hope inVent. The device is a small, single-use, in-line respirator that connects to a breathing tube and uses compressed oxygen to help move air in and out of the lungs, with no moving parts. It is designed for short-term breathing support in emergencies, disasters, battlefield settings, or ventilator shortages. Up to 5 brain-dead organ donors already on ventilators will have the device briefly replace their standard ventilator for up to 15 minutes to see if it can maintain adequate oxygen and carbon dioxide levels. There is no direct benefit to the donors, but the study could help determine if this simple, low-cost device could be useful for future patients in need of emergency ventilation.

What this could mean

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

Active substance
Hope inVent, a miniature, single-use, pressure-cycled respirator device
What this could lead to
If successful, this simple, low-cost device could provide emergency breathing support in disasters, battlefields, or ventilator shortages, potentially saving lives when standard ventilators are not available.
What could go wrong
This is a very early, first-in-human pilot study with only 5 participants, so results may not generalize. The device is tested for only 15 minutes, and any malfunction or safety concern would halt its use.

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 5 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

1 year to 100 years

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. Diagnosis of brain death 2. Provision of signed and dated informed consent form for organ donation and research by donor family or surrogate decisionmaker. 3. Male or female, with no age restriction (see size exclusion). 4. Decedent transferred to the Gift of Life at Penn Medicine Donor Care Center (study site) for routine organ donor management and organ recovery procedures. EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. Brain-dead research donor will be excluded if their baseline CO(2) or pulse oximetry is out of the accepted range for the study (defined as end tidal CO(2) between 35- and 45-mm Hg and the O(2) saturation measured by pulse oximetry \> 94%) while on optimized ventilation. 2. Brain-dead research donors with severe respiratory disease. This may include: * Bullous lung disease - noted on pre-op imaging or by history. * h/o pneumothoraces * h/o severe asthma, COPD, or other significant lung disease 3. Brain-dead research donors with morbid obesity (BMI \>=40). 4. Brain-dead research donor body weight of \< 25kg. 5. Potential Brain-dead lung transplant donors (as determined by Gift of Life Donor Program staff according to at the time of study site (Donor Care Center) admission) 6. Intraoperative arterial blood gas values outside the range of normal for pH, PaO2, PaCO2, HCO3, O2Sat as measured in pre-device ABG (while on optimized ventilation). Acceptable range for Arterial Blood Gas (ABG values) Parameter - pH / Range - 7.35-7.45 Parameter - PaO2 / Range - \>=75 mm Hg Parameter - PaCO2 / Range - 35-45 mm Hg Parameter - HCO3 / Range - 22-26 mEq/L Parameter - SpO2 / Range - 94-100

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Conditions

The condition(s) this trial relates to.

Brain Death Respiratory Aspiration

As listed by the trial registrant

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

Brain death Respiration, artificial

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

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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