Oxygenation Using a Single Portable Pulse-dose-conserving Device Compared to Combined Use of Stationary and Portable Oxygen Delivery Devices.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Percentage of time desaturated below 90% using single oxygenation system
研究概览
简要总结
Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study was designed to compare oxygen saturation and patient satisfaction with a portable oxygen concentrator or with a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with pulse dispensation for ambulation.
Methods: This cross-over trial assessed 25 patients with COPD (92% men; mean age 72.2 ± 7.4 years; mean FEV 34.14 ± 12.51%) at four hospitals in Madrid. All patients had previously used the combined system, consisting of a fixed oxygenation system and a portable system for ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while walking were determined at baseline. Patients were maintained on the previous combined system for one week and then switched to the portable oxygen concentrator for one week. Mean SpO2 over 24 hours was calculated by the software in the oximeter, and compliance was monitored
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •aged 40-80 years
- •had been diagnosed with COPD following the GOLD criteria
- •were receiving oxygen therapy using a fixed oxygenation system and a portable system for ambulation
- •without exacerbation during the previous month
- •agreed to participate
排除标准
- •terminally ill
- •unable to understand Spanish
- •had high oxygen flow at rest (> 3 lpm)
- •high respiratory frequency at rest (> 32 rpm)
- •were not achieving adequate O2 saturation levels during titration with the portable oxygen source
- •had previously been diagnosed with obstructive sleep apnea hypopnea syndrome (SAHS)
- •were receiving mechanical ventilation.
结局指标
主要结局
Percentage of time desaturated below 90% using single oxygenation system
时间窗: day 14
Oxygenation of patient during use of a portable oxygen pulse dose concentrator.
Percentage of time desaturated below 90% when using a combined oxygenation system
时间窗: at day 7
oxygenation of patient during use of a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with pulse dispensation for ambulation.
次要结局
未报告次要终点
研究者
Aina M Yañez
Epidemilogist
Hospital Son Espases