Miniature In-line Respirator

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.

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.

• 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