A Protocol for a Randomized Trial Comparing the Efficacy of Exertional Oxygen Delivery by Continuous Versus Demand-Based Flow Systems During Six-minute Walk Test in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease (OXYCODE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Lowest oxygen
研究概览
简要总结
The goal of this randomised clinical trial is to compare the efficacy of exertional oxygen delivery by continous versus demand-based flow systems in patients with fibrotic Interstitial lung disease and chronic obstructive pulmonary disease . The main questions it aim to answer:
Is there a difference in lowest oxygen saturation? Is there a difference in saturation: time below <90%, pulse rate, distance and patient preferences ? It is a cross over study, so all patients will test both methods. Participants will perform 2 6-minute walk tests with the two different oxygen delivery systems.
详细描述
The study design is a single center, randomized, open-label cross-over exploratory comparative study to investigate the efficacy of two different oxygen delivery systems. Patients with chronic obstructive Pulmonary disease or fibrotic Interstitial Lung Disease that during a six-minute walk test can walk at least 50 m and desaturate below 88%, can be included in the study. The participants are performing 2 6-minute walk tests, randomized to perform the test with oxygen bottles or portable concentrators first. Primary endpoint is the difference in the lowest oxygen saturation between the two systems. Secondary endpoints are amongst others: difference in percentage of time and number of minutes when oxygen falls below 90%, mean and maximum pulse rate, distance and time taken to recover during the 6-minute walk test and scores from questionnaires. After 3-6 months, semistructured interviews will be done to record participants' experiences of ambulatory oxygen therapy.
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
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years
- •Verified diagnosis of fibrotic interstitial lung disease or chronic obstructive pulmonary disease
- •Desaturation < 88% during 6-minute walk test or currently receiving ambulatory oxygen by continous oxygen
- •Able to walk at least 50 meters during a 6-minute walk test
- •Self-reported stable respiratory symptoms in the previous 2 weeks
- •Cognitively able to understand and participate in the study
- •Written informed consent
排除标准
- •Any physical condition including paralysis, lower extremity pain, or other musculoskeletal problems limiting exercise performance
- •Unstable heart condition or symptomatic stenotic valve disease
- •Smoking during the previous 24 hours
- •Pregnant women
- •Anemia, Hb < 7.3 mmol/l (women) or < 8.3 mmol/l (men)
- •Non-invasive ventilation
结局指标
主要结局
Lowest oxygen
时间窗: At Baseline
difference in the lowest oxygen saturation between the two different oxygen delivery systems during a 6-min. walk test.
次要结局
- Maximum pulse rate(At baseline)
- Distance(At baseline)
- time to recover(At baseline)
- percentage of saturation <90%(At baseline)
- minutes of saturation <90%(At baseline)
- Pulse rate(At baseline)
- minimum value of oxygen(At baseline)
- Maximal Borg scale(At baseline)
- Change Borg scale(At baseline)
- Comfort Likert scale(At baseline)
- comfort and frequency use oxygen(After 3-6 months)
- Patient preference(At baseline)
- Quality of life questionnaire score(After 3-6 months)
- Reliability Likert scale(At baseline)
- Semi structured qualitative interviews(After 3-6 months)
- Baseline Characteristics(After 3-6 months)
研究者
Sissel Kronborg-White
Pulmonologist
Aarhus University Hospital