Brain DeathNCT07768215
Miniature In-line Respirator
A study testing Hope inVent in people with Brain Death and Respiration, Artificial, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This first-in-human pilot study will test 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. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Brain Death, Respiration, Artificial
- What is being tested?
- Hope inVent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 1 Dec 2028
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of brain death
- Provision of signed and dated informed consent form for organ donation and research by donor family or surrogate decisionmaker.
- Male or female, with no age restriction (see size exclusion).
- Decedent transferred to the Gift of Life at Penn Medicine Donor Care Center (study site) for routine organ donor management and organ recovery procedures.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
- 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
Show all 16Show fewer
- Brain-dead research donors with morbid obesity (BMI >=40).
- Brain-dead research donor body weight of < 25kg.
- 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)
- 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
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
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Andrew Mannes, M.D., 301-594-3427, amannes@cc.nih.gov
About this study
Official title: First-In-Human Trial of Miniature In-Line, Pressure-Cycled, Emergency Respirator Device in Human Organ Donors
This first-in-human pilot study will test 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. It has no moving parts and is designed to provide short-term breathing support in situations where standard ventilators may not be available, such as emergencies, disasters, battlefield settings, transport, or ventilator shortages.
The study will enroll up to 5 brain-dead organ donors who are already receiving mechanical ventilation at the Gift of Life Donor Care Center at the Hospital of the University of Pennsylvania. Donors will only be included after authorization for organ donation and research has been obtained through standard procedures. Donors who may donate lungs or who have significant lung disease will not be included.
Read more
During the study, investigators will briefly replace the standard ventilator with the Hope inVent device for up to 15 minutes. The standard ventilator will remain immediately available, and the donor will be continuously monitored by the clinical and research teams. Investigators will measure whether the device can maintain acceptable breathing measures, including oxygen level and carbon dioxide level. They will also record breathing pressures and tidal volume, which is the amount of air delivered with each breath. If the device does not perform as expected or if any safety concern occurs, the donor will be returned immediately to the standard ventilator.
There is no direct benefit to the organ donor. Information from this study may help determine whether this type of simple, low-cost breathing device could be useful for future patients who need emergency or short-term ventilator support when standard ventilators are not available.
Read the detailed description
Study Description:
Proof of Concept pilot study to support use of a miniature in-line patient respirator for patient ventilation needs.
Objectives:
Primary Objective:
To assess the effectiveness of the miniature respirator to ventilate intubated braindead research donors while maintaining respiratory measures within acceptable range.
Secondary Objective
The miniature respirator performs as designed and tested in a lung simulator.
Endpoints:
Primary Endpoint:
A binary variable equal to 1 ("success") if both of the following criteria are met (during the placement of the test device):
- the respirator maintains the end tidal CO(2) between 35- and 45-mm Hg; and
- the O(2) saturation measured by pulse oximetry is > 94%.
Otherwise, the primary endpoint is equal to 0 ("failure").
Secondary Endpoints:
Binary variables equal to 1 ("success") if tidal volume and airway pressure settings (PEEP and maximum peak airway pressure) are within 30% of predicted values. Otherwise, the secondary endpoints are equal to 0 ("failure").
- Conditions
- Brain Death, Respiration, Artificial
- Being tested
- Hope inVent
- Keywords
- Hope inVent Respirator, Miniature In-line Respirator, Pressure-Cycled Ventilation
- Medical subject headings
- Brain Death, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hope inVentDevice
The Hope inVent is an investigational, single-use, miniature in-line respirator designed to provide short-term ventilatory support for intubated individuals. The device is a 3D-printed, pressure-cycled, gas-powered respirator with no moving parts. It connects to the endotracheal tube breathing circuit and uses compressed oxygen as its power source. In this study, only the Green Hope inVent model will be used. The device cycles between fixed pressure settings: peak inspiratory pressure of 18 cm H2O and positive end-expiratory pressure of 6 cm H2O. Enrolled brain-dead research donors will be placed on the device once for up to 15 minutes, with continuous respiratory and physiologic monitoring. The donor will then be returned to the standard mechanical ventilator.
| Study group | Role | What they receive |
|---|---|---|
| Hope inVent Miniature In-line Respirator | Experimental | All enrolled brain-dead organ donors who meet eligibility criteria will receive the investigational Green Hope inVent miniature in-line, pressure-cycled respirator for up to 15 minutes. Respiratory and physiologic measures will be collected before device placement while the donor is on the standard mechanical ventilator and during use of the Hope inVent device. Each donor serves as their own control; there is no separate comparator arm. The standard ventilator will remain available, and donors will be returned to standard ventilation after testing or earlier if safety or performance criteria require. Receives: Device: Hope inVent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of donors with successful ventilation and oxygenation during Hope inVent testing.
Success is defined as maintaining both end-tidal carbon dioxide between 35 and 45 mm Hg and oxygen saturation by pulse oximetry greater than 94% during placement of the Hope inVent device. If either criterion is not met, or if device use is stopped early because of inadequate ventilation or oxygenation, the outcome is classified as failure.
Measured: During device use, from connection of the Hope inVent device to removal, up to 15 minutes.
Secondary outcomes (3)
Proportion of donors with tidal volume within 30% of predicted value
Tidal volume will be measured using an in-line respiratory monitor while the donor is ventilated with the Hope inVent device. Each donor will be classified as a success if tidal volume is within 30% of the protocol-specified predicted value; otherwise, the donor will be classified as a failure.
Measured: During device use, from connection of the Hope inVent device to removal, up to 15 minutes.
Proportion of donors with positive end-expiratory pressure within 30% of predicted value
Positive end-expiratory pressure will be measured using an in-line respiratory monitor during Hope inVent ventilation. Each donor will be classified as a success if positive end-expiratory pressure is within 30% of the protocol-specified predicted value; otherwise, the donor will be classified as a failure.
Measured: During device use, from connection of the Hope inVent device to removal, up to 15 minutes
Proportion of donors with maximum peak airway pressure within 30% of predicted value
Maximum peak airway pressure will be measured using an in-line respiratory monitor during Hope inVent ventilation. Each donor will be classified as a success if maximum peak airway pressure is within 30% of the protocol-specified predicted value; otherwise, the donor will be classified as a failure.
Measured: During device use, from connection of the Hope inVent device to removal, up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start29 Oct 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew J Mannes, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768215
- Sponsor's protocol ID
- 10002654
- Other IDs
- 002654-CC
- Status last verified
- 12 Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified or anonymized individual donor-level data may be shared with collaborating investigators or institutions at NIH, the University of Pennsylvania, or outside institutions, and/or submitted to NIH-designated databases, consistent with donor authorization, applicable IRB approvals, NIH policies, and federal regulations. Shared data will not include direct identifiers. If coded data are shared, the code key will not be provided to collaborators. No biospecimens will be stored or shared for future use.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In-Human Trial of Miniature In-Line, Pressure-Cycled, Emergency Respirator Device in Human Organ Donors
- ClinicalTrials.gov ID
- NCT07768215
- Acronym / sponsor ID
- 10002654
- Conditions
- Brain Death, Respiration, Artificial
- Keywords
- Hope inVent Respirator, Miniature In-line Respirator, Pressure-Cycled Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 17 Aug 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.
This first-in-human pilot study will test 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. It has no moving parts and is designed to provide short-term breathing support in situations where standard ventilators may not be available, such as emergencies, disasters, battlefield settings, transport, or ventilator shortages.
The study will enroll up to 5 brain-dead organ donors who are already receiving mechanical ventilation at the Gift of Life Donor Care Center at the Hospital of the University of Pennsylvania. Donors will only be included after authorization for organ donation and research has been obtained through standard procedures. Donors who may donate lungs or who have significant lung disease will not be included.
During the study, investigators will briefly replace the standard ventilator with the Hope inVent device for up to 15 minutes. The standard ventilator will remain immediately available, and the donor will be continuously monitored by the clinical and research teams. Investigators will measure whether the device can maintain acceptable breathing measures, including oxygen level and carbon dioxide level. They will also record breathing pressures and tidal volume, which is the amount of air delivered with each breath. If the device does not perform as expected or if any safety concern occurs, the donor will be returned immediately to the standard ventilator.
There is no direct benefit to the organ donor. Information from this study may help determine whether this type of simple, low-cost breathing device could be useful for future patients who need emergency or short-term ventilator support when standard ventilators are not available.
Detailed description
Study Description:
Proof of Concept pilot study to support use of a miniature in-line patient respirator for patient ventilation needs.
Objectives:
Primary Objective:
To assess the effectiveness of the miniature respirator to ventilate intubated braindead research donors while maintaining respiratory measures within acceptable range.
Secondary Objective
The miniature respirator performs as designed and tested in a lung simulator.
Endpoints:
Primary Endpoint:
A binary variable equal to 1 ("success") if both of the following criteria are met (during the placement of the test device):
- the respirator maintains the end tidal CO(2) between 35- and 45-mm Hg; and
- the O(2) saturation measured by pulse oximetry is > 94%.
Otherwise, the primary endpoint is equal to 0 ("failure").
Secondary Endpoints:
Binary variables equal to 1 ("success") if tidal volume and airway pressure settings (PEEP and maximum peak airway pressure) are within 30% of predicted values. Otherwise, the secondary endpoints are equal to 0 ("failure").
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hope inVent Miniature In-line Respirator | Experimental | Device: Hope inVentAll enrolled brain-dead organ donors who meet eligibility criteria will receive the investigational Green Hope inVent miniature in-line, pressure-cycled respirator for up to 15 minutes. Respiratory and physiologic measures will be collected before device placement while the donor is on the standard mechanical ventilator and during use of the Hope inVent device. Each donor serves as their own control; there is no separate comparator arm. The standard ventilator will remain available, and donors will be returned to standard ventilation after testing or earlier if safety or performance criteria require. |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (16 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
- Brain-dead research donors with severe respiratory disease. This may include:
- Brain-dead research donors with morbid obesity (BMI >=40).
- Brain-dead research donor body weight of < 25kg.
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 |
|---|---|---|
| Hope inVentThe Hope inVent is an investigational, single-use, miniature in-line respirator designed to provide short-term ventilatory support for intubated individuals. The device is a 3D-printed, pressure-cycled, gas-powered respirator with no moving parts. It connects to the endotracheal tube breathing circuit and uses compressed oxygen as its power source. In this study, only the Green Hope inVent model will be used. The device cycles between fixed pressure settings: peak inspiratory pressure of 18 cm H2O and positive end-expiratory pressure of 6 cm H2O. Enrolled brain-dead research donors will be placed on the device once for up to 15 minutes, with continuous respiratory and physiologic monitoring. The donor will then be returned to the standard mechanical ventilator. | Device | Hope inVent Miniature In-line Respirator |
Primary outcome
Proportion of donors with successful ventilation and oxygenation during Hope inVent testing.
Time frame: During device use, from connection of the Hope inVent device to removal, up to 15 minutes.
Success is defined as maintaining both end-tidal carbon dioxide between 35 and 45 mm Hg and oxygen saturation by pulse oximetry greater than 94% during placement of the Hope inVent device. If either criterion is not met, or if device use is stopped early because of inadequate ventilation or oxygenation, the outcome is classified as failure.
3 secondary outcomes
Proportion of donors with tidal volume within 30% of predicted value
Time frame: During device use, from connection of the Hope inVent device to removal, up to 15 minutes.
Proportion of donors with positive end-expiratory pressure within 30% of predicted value
Time frame: During device use, from connection of the Hope inVent device to removal, up to 15 minutes
Proportion of donors with maximum peak airway pressure within 30% of predicted value
Time frame: During device use, from connection of the Hope inVent device to removal, up to 15 minutes
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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified or anonymized individual donor-level data may be shared with collaborating investigators or institutions at NIH, the University of Pennsylvania, or outside institutions, and/or submitted to NIH-designated databases, consistent with donor authorization, applicable IRB approvals, NIH policies, and federal regulations. Shared data will not include direct identifiers. If coded data are shared, the code key will not be provided to collaborators. No biospecimens will be stored or shared for future use.
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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.
Andrew J Mannes, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hope inVent in people with Brain Death and Respiration, Artificial, run by National Institutes of Health Clinical Center (CC) 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 4 inclusion and 16 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: opening soon, as of the sponsor's last update on 26 Oct 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?
Contact Tracy S Williams, R.N. ((301) 448-5366, tracy.williams@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of donors with successful ventilation and oxygenation during Hope inVent testing. (time frame: During device use, from connection of the Hope inVent device to removal, up to 15 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.