Miniature In-line Respirator
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-100
SponsorNational Institutes of Health Clinical Center (CC)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. 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.
Disqualifiers
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.
Bullous lung disease - noted on pre-op imaging or by history.
h/o pneumothoraces
h/o severe asthma, COPD, or other significant lung disease
Trial design
Design model
Single group
Treatments tested in this trial
Hope inVent
DeviceThe 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Hope inVent Miniature In-line RespiratorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of donors with successful ventilation and oxygenation during Hope inVent testing.
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.
Time frame
During device use, from connection of the Hope inVent device to removal, up to 15 minutes.Secondary outcomes
1
Proportion of donors with tidal volume within 30% of predicted value
Tidal volume will be measured using an in-line respiratory monitor while the donor is ventilated with the Hope inVent device. Each donor will be classified as a success if tidal volume is within 30% of the protocol-specified predicted value; otherwise, the donor will be classified as a failure.
Time frame
During device use, from connection of the Hope inVent device to removal, up to 15 minutes.2
Proportion of donors with positive end-expiratory pressure within 30% of predicted value
Positive end-expiratory pressure will be measured using an in-line respiratory monitor during Hope inVent ventilation. Each donor will be classified as a success if positive end-expiratory pressure is within 30% of the protocol-specified predicted value; otherwise, the donor will be classified as a failure.
Time frame
During device use, from connection of the Hope inVent device to removal, up to 15 minutes3
Proportion of donors with maximum peak airway pressure within 30% of predicted value
Maximum peak airway pressure will be measured using an in-line respiratory monitor during Hope inVent ventilation. Each donor will be classified as a success if maximum peak airway pressure is within 30% of the protocol-specified predicted value; otherwise, the donor will be classified as a failure.
Time frame
During device use, from connection of the Hope inVent device to removal, up to 15 minutesSponsors and contacts
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Source ClinicalTrials.gov
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