Miniature In-line Respirator
First-In-Human Trial of Miniature In-Line, Pressure-Cycled, Emergency Respirator Device in Human Organ Donors
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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):
-
the respirator maintains the end tidal CO(2) between 35- and 45-mm Hg;
and
-
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").
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Tracy S Williams, R.N.
- Номер телефона: (301) 448-5366
- Электронная почта: tracy.williams@nih.gov
Учебное резервное копирование контактов
- Имя: Andrew J Mannes, M.D.
- Номер телефона: (301) 594-3427
- Электронная почта: amannes@cc.nih.gov
Места учебы
-
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Hospital of the University of Pennsylvania
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Контакт:
- Andrew Mannes, M.D.
- Номер телефона: 301-594-3427
- Электронная почта: amannes@cc.nih.gov
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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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:
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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.
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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
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Brain-dead research donors with morbid obesity (BMI >=40).
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Brain-dead research donor body weight of < 25kg.
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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)
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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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Возможности устройства
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of donors with successful ventilation and oxygenation during Hope inVent testing.
Временное ограничение: 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. |
During device use, from connection of the Hope inVent device to removal, up to 15 minutes.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of donors with tidal volume within 30% of predicted value
Временное ограничение: 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. |
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
Временное ограничение: 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. |
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
Временное ограничение: 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. |
During device use, from connection of the Hope inVent device to removal, up to 15 minutes
|
Соавторы и исследователи
Следователи
- Главный следователь: Andrew J Mannes, M.D., National Institutes of Health Clinical Center (CC)
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Патологические процессы
- Заболевания дыхательных путей
- Нейроповеденческие проявления
- Нарушения дыхания
- Смерть
- Расстройства сознания
- Бессознательное состояние
- Кома
- Патологические состояния, признаки и симптомы
- Респираторная аспирация
- Смерть мозга
Другие идентификационные номера исследования
- 10002654
- 002654-CC
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
De-identified or anonymized individual donor-level data may be shared with collaborating investigators or institutions at NIH, the University of Pennsylvania, or outside institutions, and/or submitted to NIH-designated databases, consistent with donor authorization, applicable IRB approvals, NIH policies, and federal regulations. Shared data will not include direct identifiers. If coded data are shared, the code key will not be provided to collaborators. No biospecimens will be stored or shared for future use.
Сроки обмена IPD
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.
Критерии совместного доступа к IPD
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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .