Aviation Portable Oxygen Delivery System Based on Pneumatic Pulse Technology
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Device performance, as measured by SpO2
研究概览
简要总结
This study aims to investigate dose based oxygen delivery vs. continuous flow of oxygen during simulated altitude conditions as would be experienced after a loss of pressure during commercial aircraft flight. Testing will be performed at rest and during light exercise at a simulated altitude of 15,000 feet in a hypobaric chamber. Performance of the two oxygen delivery systems will be compared using oxygen saturation determined by pulse oximetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers
排除标准
- •pregnancy
- •sickle cell trait
- •cardiovascular or pulmonary disease
- •significant ear or sinus problems that would prevent equalization during pressure change
- •estimated VO2peak <35 mL/kg per minute (males) or <30 mL/kg per minute (females)
研究组 & 干预措施
Pneumatic Pulsed Flow
Oxygen delivery using test method
干预措施: Integra Pulse Portable- Pneumatic pulsed flow (Device)
Continuous Flow
Oxygen delivery at 4 liters per minute is the standard method
干预措施: Integra Pulse Portable- Continuous flow (Device)
结局指标
主要结局
Device performance, as measured by SpO2
时间窗: one minute
The same subject must complete both oxygen delivery system exposures for the data to be used in system performance analysis. Equivalence of the two oxygen delivery systems will be defined as the lack of statistically significant difference (N=20) in SpO2 during the last minute of exercise between the pulse and continuous flow oxygen delivery systems. Average minimum SpO2 over the last minute of the test period will be reported.
次要结局
未报告次要终点