Comparing Known Modes of Ventilation Delivered by Trilogy Versus Conventional Mechanical Ventilators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).
研究概览
简要总结
The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device). Both devices will be set to the participants' current mode and prescription settings.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).
时间窗: After one hour of ventilator use
Blood gas was obtained for this study one hour after use of each device.
Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.
时间窗: After one hour of ventilator use
Pulse Oximetry was measured after one hour of use of each ventilator.
次要结局
- Tidal Volume(One hour during ventilator use.)
- Minute Ventilation(One hour during ventilator use.)
- Hemodynamics (Heart Rate)(One hour during ventilator use.)