First-In-Human Trial of Miniature In-Line, Pressure-Cycled, Emergency Respirator Device in Human Organ Donors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Proportion of donors with successful ventilation and oxygenation during Hope inVent testing.
Study Overview
Brief 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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 100 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •INCLUSION CRITERIA
- •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.
Exclusion Criteria
- •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
- •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
Arms & Interventions
Hope inVent Miniature In-line Respirator
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.
Intervention: Hope inVent (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Proportion of donors with tidal volume within 30% of predicted value(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(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(During device use, from connection of the Hope inVent device to removal, up to 15 minutes)