Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Inogen Inc.
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
研究概览
简要总结
The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine whether the device can adequately maintain oxygen saturation during sleep.
详细描述
The study design is a prospective, single site, single arm, open label, pilot study. The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine whether the device can adequately maintain oxygen saturation during sleep, i.e., achieve target with initial titration setting and/or with any needed adjustments of setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects may be of any gender
- •Subject's age must be 40 - 80 years
- •Subjects must have a current prescription for nocturnal oxygen < 3 L/min continuous or current use of a Portable Oxygen Concentrator.
排除标准
- •Subject is using any ancillary medical device(s) that may interfere with the operation of or data interpretation from the InogenOne device (such as CPAP/BiPAP, NIV).
- •Subjects with nasal obstruction
- •Subjects taking any drugs that affect respiratory center drive
- •Subject has an acute illness or hospitalization within the last 30 days
- •Subject has a change in medication within the last 15 days
- •Subject is currently receiving respiratory stimulant medications (such as acetazolamide, medroxyprogesterone, doxapram, theophylline/aminophylline, protriptyline and buspirone)
- •Subject has significant comorbidities that in the opinion of the Investigator would interfere with outcomes and/or study conduct
- •Subject's prescribed treatment is in conflict with study procedures
- •Subjects with any unstable disease
研究组 & 干预措施
InogenOne Rove 6 Portable Oxygen Concentrator
InogenOne Rove 6 Portable Oxygen Concentrator
干预措施: InogenOne Rove 6 Portable Oxygen Concentrator (Device)
结局指标
主要结局
Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
时间窗: 6 hours overnight
oxygen saturation (SpO2)
次要结局
- Number/% of subjects requiring increased settings and the difference between initial and maximal settings required to meet target SpO2 ≥90% for >30% of sleep time criteria(6 hours overnight)
- Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting(6 hours overnight)
- Minimum/maximum SpO2 on initial setting and maximal setting(6 hours overnight)
- Time/% time above/below 90% target on initial setting and maximal setting(6 hours overnight)