Automated Oxygen Titration to Patients with COPD and Domiciliary Long-term Oxygen Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Percentage of time in intended SpO2-interval
研究概览
简要总结
O2matic HOT is a further development of O2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (LTOT). O2matic HOT is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. In this crossover trial patients are admitted for 24 hours twice. Once with usual fixed dose oxygen and once with oxygen titration by O2matic HOT.
详细描述
The purpose of this study is to examine if automated oxygen control based on pulse oximetry to patients with domiciliary long-term oxygen treatment (LTOT) is better than manually controlled oxygen treatment in keeping SpO2 within intended target interval. In manually controlled oxygen treatment flow is usually kept constant for months between visits from specialist nurse, whereas in automated control the patient can titrate oxygen flow several times a day based on pulse oximetry in a closed-loop system.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified COPD with FEV1/FVC < 0.70
- •Need of LTOT (PaO2 <= 7.3 kPa or SpO2 < 88 % on ambient air)
- •Cognitively able to participate
- •Willing to provide informed consent
排除标准
- •Moderate or severe exacerbation in COPD within 4 weeks from study start
- •Major comorbidities (cancer, uncontrolled chronic disease)
- •Asthma or other disease with need of higher SpO2
- •Pregnancy
- •Fall in pH below 7.35 or increase in PaCO2 > 1 kPa on 5 liters of oxygen
- •Active smoking
- •LTOT use less than 1 hours/day
结局指标
主要结局
Percentage of time in intended SpO2-interval
时间窗: 24 hours
Percentage of time with SpO2 in intended interval
次要结局
- Percentage of time with SpO2 below 85 %(24 hours)
- Percentage of time with SpO2 above target(24 hours)
- Percentage of time with SpO2 below target but not below 85 %(24 hours)
- Change in PaCO2 from baseline(24 hours)
- Accumulated oxygen usage(24 hours)
- Adverse and serious adverse events(24 hours)
研究者
Ejvind Frausing Hansen
Chief Physician
Hvidovre University Hospital