National Institutes of Health Clinical Center (CC)
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…
* 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 baseli…
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.