First-In-Human Trial of Miniature In-Line, Pressure-Cycled, Emergency Respirator Device in Human Organ Donors
| Registry | NCT07768215 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, device feasibility |
| Enrollment | 5 (Estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) (Nih) |
| Conditions | Brain Death, Respiration, Artificial |
| Interventions | Hope inVent (Device) |
| Dates | start 2026-10-26 (estimated), primary completion 2028-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-08-17, last updated 2026-10-21 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Brain Death All trials for Respiration, Artificial All trials of Hope inVent
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 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):
1. the respirator maintains the end tidal CO(2) between 35- and 45-mm Hg;
and
2. 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").
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Hope inVent Miniature In-line Respirator | Experimental | Device: Hope inVent | 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. |
Sex: All, ages: 1 Year to 100 Years
* 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
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania | United States |