Miniature In-line Respirator
Brain Death · Respiration, Artificial
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 1 años - 100 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 5 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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. the respirator maintains the end tidal CO(2) between 35- and 45-mm Hg;
and
2. the O(2) saturation measured by pulse oximetry is \> 94%.
Otherwise, the primary endpoint is equal to 0 ("failure").
Secondary Endpoints:
Binary variables equal to 1 ("success") if tidal volume and airway pressure settings (PEEP and maximum peak airway pressure) are within 30% of predicted values. Otherwise, the secondary endpoints are equal to 0 ("failure").
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
- 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
Entiende la evaluación inicialTratamiento, grupos y participación
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- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
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.
Device: Hope inVent
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Proportion of donors with successful ventilation and oxygenation during Hope inVent testing.
Plazo: 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.
Medidas secundarias
Proportion of donors with tidal volume within 30% of predicted value
Plazo: During device use, from connection of the Hope inVent device to removal, up to 15 minutes.
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.
Proportion of donors with positive end-expiratory pressure within 30% of predicted value
Plazo: During device use, from connection of the Hope inVent device to removal, up to 15 minutes
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.
Proportion of donors with maximum peak airway pressure within 30% of predicted value
Plazo: During device use, from connection of the Hope inVent device to removal, up to 15 minutes
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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- National Institutes of Health Clinical Center (CC)
- Inicio del estudio
- 15 nov 2026 Estimado
- Finalización primaria
- 1 dic 2028 Estimado
- Finalización del estudio
- 1 dic 2028 Estimado
- Primera publicación
- 17 ago 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
First-In-Human Trial of Miniature In-Line, Pressure-Cycled, Emergency Respirator Device in Human Organ Donors
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026