Miniature In-line Respirator
Public ClinicalTrials.gov record NCT07768215. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
First-In-Human Trial of Miniature In-Line, Pressure-Cycled, Emergency Respirator Device in Human Organ Donors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07768215
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 5 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 7, 2026
- Primary completion
- Nov 30, 2028
- Completion
- Nov 30, 2028
- Last update posted
- Sep 2, 2026
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07768215, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07768215 live on ClinicalTrials.gov.