Trilogy Comparison Study - Adults
Comparing Known Modes of Ventilation Delivered by Trilogy Versus Conventional Mechanical Ventilators
研究概览
详细说明
A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as partial pressure of CO2 in arterial or venous blood)and SpO2 levels during various modes of ventilation.
B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Manitoba
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Winnipeg、Manitoba、加拿大、R3E 0Z3
- University of Manitoba
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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
Inclusion Criteria:
- Age > 21 years of age; < 85 years of age
- Able to follow instructions
- Able to provide informed consent
- Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O.
- Requiring mechanical ventilation through nasal/facial mask,tracheostomy or endotracheal tube (ET Tube)
Exclusion Criteria:
Clinically unstable, i.e.,
- Acute Respiratory Failure
- Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents),
- Uncontrolled cardiac ischemia or arrhythmias,
- or as otherwise determined inappropriate for the study as determined by the investigator.
- Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Trilogy
Trilogy Device
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Exposure for one hour on the Trilogy ventilator
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有源比较器：Standard of Care
Participants prescribed ventilator
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Exposure to participants current ventilator
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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 |
|---|---|---|
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Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).
大体时间：After one hour of ventilator use
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Blood gas was obtained for this study one hour after use of each device.
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After one hour of ventilator use
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Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.
大体时间：After one hour of ventilator use
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Pulse Oximetry was measured after one hour of use of each ventilator.
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After one hour of ventilator use
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tidal Volume
大体时间：One hour during ventilator use.
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Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.
It measures around 500 mL in an average healthy adult male and approximately 400 mL in a healthy female.
Average tidal volume was compare after a hour of use of each device.
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One hour during ventilator use.
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Minute Ventilation
大体时间：One hour during ventilator use.
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Minute ventilation is the volume of gas inhaled or exhaled from a person's lungs per minute.
This was measured after one hour of use of each device.
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One hour during ventilator use.
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Hemodynamics (Heart Rate)
大体时间：One hour during ventilator use.
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Number of beats per minute.
Measured after one hour of use of each device.
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One hour during ventilator use.
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合作者和调查者
调查人员
- 首席研究员：Steven Mink, MD、University of Manitoba
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
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