Automated Oxygen Titration to Improve Activities of Daily Living in Patients With Chronic Obstructive Pulmonary Disease on Home Oxygen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time used for the Glittre-ADL test
研究概览
简要总结
The purpose of this study is to examine the effect of automated oxygen titration compared to the usual fixed dose oxygen on the patient's ability to perform activities of daily living.
详细描述
The patient's ability to perform ADL assessed by the Glittre-ADL test with automatic oxygen titration compared to usual fixed dose will be examined.
The patients will be invited to a visit at one of the participating hospitals. The Glittre-ADL will be performed according to the protocol validated by Skumlien et al. The first test is performed for familiarization in order to avoid a learning effect in the primary tests. The patients will use the fixed-dose oxygen, established after titration to a SpO2 of 90-94 % at rest.
After the familiarization test and gathering of demographics, further two Glittre-ADL tests will be performed on the same day or at another day pending on patient preference. In random order the patients will use A) automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min and B) their usual fixed dose of oxygen. In both arms O2matic will monitor pulse rate and saturation continuously during the test, but only in the automated oxygen therapy arm O2matic adjusts the oxygen flow. The patients will all use a rollator as walking aid. The oxygen equipment will be placed in the rollator and the tests will be conducted without the steps (due to the use of rollator). The minimum interval between tests will be 20 minutes or until the vital values and symptoms are returned to baseline. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale.
Study Analysis Plan
- Paired sample t-test: time used in the Glittre test using AutOx vs Time used using Fixed oxygen (in seconds)
- Paired sample t-test: Borg score after Glittre using Autox vs Borg score after Glittre when using Fixed oxygen (on a scale from 0-10) A test for carryover effect will be performed by comparing the first and the second tests before being divided into the Autox and fixed oxygen groups.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The patient will be blinded for the oxygen supply. An independent person will prepare the oxygen setup with usual fixed dose or automated titration. The setup i covered. The assessor conducting the tests is blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified history of COPD with FEV1/FVC < 0.70 and FEV1 < 50 %
- •Hypoxemic at rest (SpO2≤ 90 %) and fulfilment of general national criteria for LTOT
- •Partial pressure of Oxygen (PaO2) (without oxygen supplement) ≤7.3 kPa in clinically stable and optimally treated condition
- •Increase in PaO2 after oxygen supplementation (to 8.0-9.0 kPa) without decrease in arterial pH (> 0.03 kPa)
- •The oxygen is used at least 15 hours daily (optimally 24 hours daily)
- •The treatment is handled by hospital departments with lung medical expertise.
- •Able to walk at least 30 meters
- •Age >18, Cognitively able to participate in the study and willing to give informed consent
排除标准
- •Pulmonary or cardiac condition other than COPD limiting physical performance
- •Unstable heart condition or stenotic aortic valve disease
- •A physical condition including paralysis, lower extremity pain, or back problem limiting physical performance
- •Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks
研究组 & 干预措施
Usual oxygen dose
A Glittre-ADL tests will be performed and the patients will use their usual fixed dose of oxygen. Pulse rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale
Automated oxygen dose
A Glittre-ADL tests will be performed and the patients will use automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min. Pulse rate, oxygen flow rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale
干预措施: Automated oxygen titration based on the oxygen saturation during activity (Other)
结局指标
主要结局
Time used for the Glittre-ADL test
时间窗: Immediately after intervention (control arm test and automated oxygen titration arm) on the same day
Change in time used to complete the Glittre-ADL test with automated titration compared to fixed-dose treatment
次要结局
- Saturation(Immediately after the intervention)
- Dyspnea(Immediately after the intervention)
- Oxygen consumption(Immediately after the intervention)
研究者
Linette Marie Kofod
Physiotherapist, Primary investigator
Copenhagen University Hospital, Hvidovre