Automated Oxygen Titration in Daily Life of Patients With Chronic Obstructive Pulmonary Disease on Home Oxygen Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Feasibility of using automated oxygen titration at home
研究概览
简要总结
Twelwe patients with COPD and long term oxygen treatment (LTOT) will be included in the study. An automated home oxygen titrations (HOT) device will be attached to the patient´s home oxygen equipment. For 2x4 consequent days, the patients will be monitored and saturations, oxygen flow and physical activity level will be registered. In randomized order, the patients will use their usual fixed oxygen dose or automated oxygen titration during the first four days and then crossover. The monitoring consists of a wrist pulse oximeter (register pulse and saturation which is send to the HOT device) and a physical activity sensor attached to the patient's knee. At study start and after both of the four days the patients´dyspnea and QoL will be assessed.
After the study period the patients will in an explorative design based on qualitative methodology be interviewed in order to explore the patients experiences with automated oxygen titration during daily activity and on dyspnea.
详细描述
Twelve patients with COPD and long term oxygen treatment (LTOT) will be included in the study. The purpose is to evaluate the feasibility of automated oxygen titration during daily living incl. activities. The pilot feasibility design has been chosen as this will be
- the first study testing automated oxygen titration in the patients' home,
- the first study testing automated oxygen titration adjusted not only at rest but during the entire day with the possibility to deliver up to 8 l/min.
Demographic data, will be registered. Oxygen consumption and oxygen saturation (SpO2) will be registered. O2matic Home Oxygen Treatment (HOT) is a device, which based on continuous, non-invasive measurement of SpO2 adjusts oxygen flow to the patient within a defined target interval. SpO2-target can be set individually, but in this study will be fixed at 90 to 94 % with a flow from 0.5-8 l/min. If SpO2 falls below 90 % oxygen flow will increase, and if SpO2 increases above 94 % oxygen flow will decrease. The adjustments are done every second based on average SpO2 for the last 15 seconds.
Blood gas analysis (ABG): Two venous blood sample will be taken, the first with the usual oxygen dose and the second after 20 minutes with an oxygen flow of 8 l/min. The analysis will look at pH-value and the PvCO2.
Clinical COPD Questionnaire (CCQ): 24-hour CCQ measures health status and can be used to assess health-related quality of life (HRQL). It measures symptoms within the last 24 hours as well as functional and mental state, and it is a predictor of mortality in patients with COPD. It is a short questionnaire with 10 items rated on a scale with 6 grades. The items are dyspnea at rest and on exercise, fear of worsening in the condition, depression, cough and sputum, limitations with strenuous and moderate physical activity, limitations with daily activities and social activities. Besides the total score ranging from 0 to 6 there are 3 subscores representing symptoms, mental state and functional state. An improvement of 0.4 is considered clinically significant. CCQ is validated in several languages including danish, and has proven to have good reliability and validity and to be responsive to changes and interventions, such as exacerbations, pulmonary rehabilitation and smoking cessation.
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
盲法说明
The two different oxygen doses at home is randomised after the initial assessment. It is not possible to blind the patients nor the investigator in this feasibility design.
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
- •The patients will also be excluded if they have a drop in pH to < 7,31 (venous blood gas) on 8 litres per minute of oxygen flow OR an increase in PvCO2 on > 1 kPa compared to usual fixed oxygen dose.
结局指标
主要结局
Feasibility of using automated oxygen titration at home
时间窗: Immediately after the 2x4 days intervention
Automated oxygen titration during daily living will be considered feasible if 1. Data is successfully transmitted from the wrist pulse oximeter to O2matic HOT and further to the cloud solution (\<10 % data loss). 2. The patients are wearing the wrist pulse oximeter for more than 50 % of the daytime (08:00 - 20:00) 3. The time spent within acceptable SpO2-interval is statistically different between arms and in favor of automated oxygen titration with a difference of at least 10 percentage difference in time. 4. The patients are at least as active with O2matic HOT as with conventional oxygen therapy, measured by SENS activity monitor. 5. The patients are safe with no serious adverse events, including hypercapnia leading to unscheduled healthcare contacts.
次要结局
- Physical activity(Immediately after the intervention)
- Change in CCQ-score(Immediately after the intervention)
研究者
Linette Marie Kofod
Physiotherapist, Primary investigator
Hvidovre University Hospital