Chronic Hypoxemic Respiratory Failure, COPD
Conditions
Keywords
O2matic, Closed-loop, Pulse oximetry
Brief summary
O2matic HOT is a further development of O2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (LTOT). O2matic HOT is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. In this crossover trial patients are admitted for 24 hours twice. Once with usual fixed dose oxygen and once with oxygen titration by O2matic HOT.
Detailed description
The purpose of this study is to examine if automated oxygen control based on pulse oximetry to patients with domiciliary long-term oxygen treatment (LTOT) is better than manually controlled oxygen treatment in keeping SpO2 within intended target interval. In manually controlled oxygen treatment flow is usually kept constant for months between visits from specialist nurse, whereas in automated control the patient can titrate oxygen flow several times a day based on pulse oximetry in a closed-loop system.
Interventions
DEVICEO2matic HOT
Automated oxygen titration with O2matic HOT
DEVICEOxygen concentrator
Fixed dose oxygen flow from concentrator
Sponsors
Innovation Fund Denmark
Naestved Hospital
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Verified COPD with FEV1/FVC \< 0.70 * Need of LTOT (PaO2 \<= 7.3 kPa or SpO2 \< 88 % on ambient air) * Cognitively able to participate * Willing to provide informed consent
Exclusion criteria
* Moderate or severe exacerbation in COPD within 4 weeks from study start * Major comorbidities (cancer, uncontrolled chronic disease) * Asthma or other disease with need of higher SpO2 * Pregnancy * Fall in pH below 7.35 or increase in PaCO2 \> 1 kPa on 5 liters of oxygen * Active smoking * LTOT use less than 1 hours/day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in intended SpO2-interval | 24 hours | Percentage of time with SpO2 in intended interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time with SpO2 below target but not below 85 % | 24 hours | Percentage of time with SpO2 below target but not below 85 % |
| Percentage of time with SpO2 above target | 24 hours | Percentage of time with SpO2 above target |
| Percentage of time with SpO2 below 85 % | 24 hours | Percentage of time with SpO2 below 85 % |
| Accumulated oxygen usage | 24 hours | Accumulated oxygen usage in 24 hours |
| Adverse and serious adverse events | 24 hours | Adverse and serious adverse events, such as respiratory acidosis |
| Change in PaCO2 from baseline | 8 hours | Change in PaCO2 from baseline to 8 hours |
Countries
Denmark
Outcome results
None listed