Auto-titrating Oxygen in Chronic Respiratory Failure
关键词
抽象
描述
For patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), disease progression leads to hypoxic respiratory failure necessitating the use of long-term oxygen therapy (LTOT). However a number of studies have shown that despite being on LTOT at home many patients with COPD still experience episodes of intermittent hypoxia (reduction in oxygen saturation <90%). These episodes occur during rest, sleep, talking, walking and sleep. These episodes of intermittent hypoxia can be harmful as they can lead to the development of ischaemic heart disease, induce pulmonary hypertension and affect brain function.
In order to reduce these episodes of intermittent hypoxia, the investigators have designed an auto-titrating, closed-loop oxygen system which automatically adjust the flow of oxygen to match a given oxygen saturation target. This allows individualisation and optimisation of oxygen therapy for every patient.
Mechanism of action:
A pulse oximeter is attached to the ear or finger of a patient. This send the oxygen saturation reading to a control centre (located in a mobile phone). The control centre is pre-programmed to maintain a set oxygen saturation target. The control centre outputs a signal to a flow meter which regulated the outflow of oxygen.
In this study, the investigators will recruit patients with COPD on LTOT and patients with IPF on LTOT or ambulatory oxygen to undergo three 6 minute walk tests (6MWT). The first will be on air (practice walk), the second will be on their usual ambulatory oxygen and the third on the auto-titrating oxygen system. The order of the second and third walks be randomly selected. The patient will be blinded as to which type of oxygen they will be receiving in the second and third walk.
Hypothesis: the investigators iO2t system is better at preventing and treating oxygen desaturations that occur during a 6MWT than usual fixed flow ambulatory oxygen therapy
日期
| 最后验证: | 08/31/2014 |
| 首次提交: | 09/11/2014 |
| 提交的预估入学人数: | 09/18/2014 |
| 首次发布: | 09/24/2014 |
| 上次提交的更新: | 02/14/2016 |
| 最近更新发布: | 02/16/2016 |
| 实际学习开始日期: | 06/30/2014 |
| 预计主要完成日期: | 10/31/2015 |
| 预计完成日期: | 10/31/2015 |
状况或疾病
干预/治疗
Device: Auto-titrating arm
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| No Intervention: Fixed flow oxygen The 6MWT will done on the patients usual fixed flow ambulatory oxygen in this arm. | |
| Experimental: Auto-titrating arm The 6MWT will done using the auto-titrating oxygen system in this arm of the study | Device: Auto-titrating arm The auto-titrating oxygen system contains a number of components working together to produce variable oxygen flow. An oximeter measures the oxygen saturation of a patient and via Bluetooth this is relayed to a control centre in a mobile phone. This in turn regulates a flow meter which adjust oxygen flow. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - COPD and on LTOT - IPF on LTOT or ambulatory oxgen Exclusion Criteria: - Unable to mobilise for a 6 minute walk test - Unable to consent to study, - Partial pressure of oxygen < 6.0 kilopascals (kPa) or Partial pressure of carbon dioxide > 8kilopascals on air, - Exacerbation of the underlying lung disease in the previous 4 weeks - Unstable cardiovascular disease (e.g. arrhythmia, hypertension/hypotension or angina) - Pregnancy |
结果
主要结果指标
1. The percentage of time spent with oxygen saturation below 90% [Assessed at the completion of the 6 minute walk test/s]
次要成果指标
1. Total distance walked [Assessed at the completion of the 6 minute walk test]
2. Mean oxygen saturation [Assessed during the 6MWT]
3. Total Volume of oxygen delivered [Assessed at the completion of the 6 minute walk test]
