Intelligent oxygen therapy in type II respiratory failure during sleep
Research type
Research Study
Full title
The assessment of an auto-titrating oxygen system (intelligent oxygen therapy [iO2T]) in patients with hypercapnic respiratory failure on long-term oxygen therapy during sleep
IRAS ID
177788
Contact name
Anita Simonds
Contact email
Clinicaltrials.gov Identifier
15IC2590, Imperial College London Joint Research Compliance Office Reference number
Duration of Study in the UK
1 years, 3 months, 27 days
Research summary
Summary of Research
The aim of this study is to investigate whether a new oxygen delivery system can control carbon dioxide levels during sleep in patients who have a raised carbon dioxide level during the day and who are currently on long-term oxygen therapy (LTOT).
Patients on LTOT can experience high levels of carbon dioxide during the night which can lead to symptoms such as morning headache, drowsiness and poor sleep. We have developed an auto-titrating oxygen system (which we have named “intelligent oxygen therapy” [iO2t] system), which can control oxygen levels tightly and hence reduce the chance of patients receiving too much or too little oxygen. In this study, we will ask participants who are on LTOT and who have a raised carbon dioxide during the day to have two home sleep studies on two consecutive days; one on their usual long-term oxygen therapy and one on our new iO2t system. The sleep study we will conduct is carried out routinely in clinical practice on many patients every year. Participants will be asked to wear a number of instruments during the sleep study; this will include electrodes on the head to monitor brain activity, an oxygen sensor on the finger, chest and abdominal bands to measure movement, and a carbon dioxide monitor on the ear. Oxygen will be supplied as usual from a concentrator or a cylinder but will be routed through the iO2t system in order to allow tight control. The most important outcome we will measure is the change in the carbon dioxide levels overnight whilst the participants are using the two different oxygen delivery systems.Summary of Results
People with respiratory failure due to COPD and other causes using long term ambulatory oxygen therapy took part in a randomised crossover study where they were assessed doing standardised activities of daily living such as dressing and undressing, bathing, putting on and off shoes, washing dishes, sweeping the floor - using a conventional fixed flow oxygen, or an intelligent oxygen flow system (iO2Ts) that adjusted flow to the individual's oxygen level. The aim was too see whether the iO2Ts reduced periods of low level oxygen during th activities compared to the fixed flow system, and could be be used as an assessment tool.
The results in 25 patients showed a significant reduction in the percentage of time spent below 90% oxygen saturation in the iO2Ts group (17.2% fixed flow versus 3.6% iO2Ts p=0.006). The iO2T2 system also reduced the time spent at levels of greater than 97% (hyperoxia).The minimum level of arterial oxygen duration was higher in the iO2Ts group although mean saturation, heart rate and levels of breathlessness did not differ.
Different individual patterns of oxygen use and arterial oxygen saturation emerged form the trial suggesting that the iO2Ts could be a useful assessment tool to personalise oxygen delivery.
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbapvbma-2FSP4E8Oa28SzxMdVVQ-2BqwXW7rRx2J-2FJQzo8yhMZKu5HVw6pkI-2F4E2aZKp1iEn5vLwSL4iyUosB4-2BWkDc-2Bovhc-2FVUU9x3SXnYBfjVeh8O-2FKj-2FL-2B8wzZz6Rea1R4ZXoCKdW2gfHbrpRMKJbAaohztu-2FKHirjSvAn8BwOWNHDlpr_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJEu34jLayPpqdrjoQmtzk-2BZcOLCTNsHhS2aUSAdSghx8siT3nH5f03NJOEBTcTsQwz3flOH-2BYHv7PDUy1VLb2LdDFmPJ2bEzzbkJltnYBNPUzfdO1W66Z8Fy5fSh7UgKaSyAqdTAoeulBir7Re8TW0R99cnKD1wU9PgN-2Bk32auYw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C555b45ff0f1e4f2d6db908db0d171abf%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638118165101187393%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=deMtGqZEx2ASQY3%2BnUd52kT0qJKcUWxyvkO8HC2sad0%3D&reserved=0REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
15/WM/0137
Date of REC Opinion
23 Oct 2015
REC opinion
Further Information Favourable Opinion