Automated Oxygen Titration With O2matic Home Oxygen Therapy (O2matic HOT) Phase 1

Study Overview
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Brief Summary
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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
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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.

Official Title
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Automated Oxygen Titration to Patients With COPD and Domiciliary Long-term Oxygen Treatment

Conditions
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COPD, Chronic Hypoxemic Respiratory Failure

Intervention / Treatment
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* Device: O2matic HOT
* Device: Oxygen concentrator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual<br>Fixed dose oxygen | Device: Oxygen concentrator<br>* Fixed dose oxygen flow from concentrator<br>|
| Experimental: O2matic<br>Automated oxygen titration | Device: O2matic HOT<br>* Automated oxygen titration with O2matic HOT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in intended SpO2-interval | Percentage of time with SpO2 in intended interval | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time with SpO2 below 85 % | Percentage of time with SpO2 below 85 % | 24 hours | 
| Percentage of time with SpO2 below target but not below 85 % | Percentage of time with SpO2 below target but not below 85 % | 24 hours | 
| Percentage of time with SpO2 above target | Percentage of time with SpO2 above target | 24 hours | 
| Change in PaCO2 from baseline | Change in PaCO2 from baseline to 8 hours | 8 hours | 
| Change in PaCO2 from baseline | Change in PaCO2 from baseline to 24 hours | 24 hours | 
| Accumulated oxygen usage | Accumulated oxygen usage in 24 hours | 24 hours | 
| Adverse and serious adverse events | Adverse and serious adverse events, such as respiratory acidosis | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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O2matic, Closed-loop, Pulse oximetry