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.
研究概览
详细说明
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").
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Tracy S Williams, R.N.
- 电话号码：(301) 448-5366
- 邮箱：tracy.williams@nih.gov
研究联系人备份
- 姓名：Andrew J Mannes, M.D.
- 电话号码：(301) 594-3427
- 邮箱：amannes@cc.nih.gov
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
-
接触：
- Andrew Mannes, M.D.
- 电话号码：301-594-3427
- 邮箱：amannes@cc.nih.gov
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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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
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of donors with successful ventilation and oxygenation during Hope inVent testing.
大体时间：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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of donors with tidal volume within 30% of predicted value
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
调查人员
- 首席研究员：Andrew J Mannes, M.D.、National Institutes of Health Clinical Center (CC)
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 10002654
- 002654-CC
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
IPD 共享时间框架
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.
IPD 共享访问标准
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.
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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