Miniature In-line Respirator

NCT07768215 | Not Yet Recruiting

• 2 other identifiers: 10002654002654-CC
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Death; Respiration, Artificial

Keywords

Hope inVent Respirator; Miniature In-line Respirator; Pressure-Cycled Ventilation

Outcome Measures

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.

  During device use, from connection of the Hope inVent device to removal, up to 15 minutes.

Secondary Outcomes (3)

• 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

Study Arms (1)

Hope inVent Miniature In-line Respirator

EXPERIMENTAL

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.

Device: Hope inVent

Interventions

Hope inVent DEVICE

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.

Hope inVent Miniature In-line Respirator

Eligibility Criteria

• Age: 1 Year - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of brain death
• Provision of signed and dated informed consent form for organ donation and research by donor family or surrogate decisionmaker.
• Decedent transferred to the Gift of Life at Penn Medicine Donor Care Center (study site) for routine organ donor management and organ recovery procedures.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Brain Death; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Andrew J Mannes, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy S Williams, R.N.

CONTACT

(301) 448-5366; tracy.williams@nih.gov

Andrew J Mannes, M.D.

CONTACT

(301) 594-3427; amannes@cc.nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): October 7, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-08-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified or anonymized individual participant data and supporting information may become available after publication of the primary study results or posting of summary results on ClinicalTrials.gov, subject to applicable consent/authorization, IRB approvals, data-use agreements, and NIH/federal requirements.
• Access Criteria: De-identified or anonymized donor-level data may be shared with qualified investigators at NIH, the University of Pennsylvania, or other institutions upon written request to the Principal Investigator. Requests must describe the proposed scientific use, such as analyses of device performance, respiratory/physiologic outcomes, safety, or related protocol objectives. Requests will be reviewed by the study team/sponsor and shared only as permitted by donor authorization, IRB approvals, institutional policies, data-use or collaboration agreements, and NIH/federal requirements. Data may be shared with investigators/institutions with a Federalwide Assurance or operating under the Declaration of Helsinki; other sharing will require prospective IRB approval. Data may be transferred securely or submitted to an NIH-designated database. Direct identifiers and code keys will not be shared.

Locations

US (1)