Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device

Study Overview
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Brief Summary
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The aim of our study is to assess if an automated titration of oxygen flow during exertion can be a useful tool to determinate the level of oxygen required by COPD patients that are using oxygen therapy during exercise.

Detailed Description
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All patients referred to our centre of oxygen titration during exertion will be offered to participate in our study. After baseline assessments, patients will have an oxygen titration using two different methods in random order: Usual titration protocol will include an manual oxygen increase during a titration 6 minutes walk test Automatic titration protocol that will use the automated oxygen titration device to adjust oxygen flow rate during a titration 6 minutes walk test. After each titration protocol, the efficacy of the titration will be assessed in 3 validation 6 minutes walk tests during which oxygen flow will be set at: The manually determined flow rate The 95th percentile flow rate of the automatic titration The median flow rate of the automatic titration During validation 6 minutes walk test, oxygen saturation, dyspnea, walked distance and heart rate will be recorded.

Official Title
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Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device: a Monocentric, Prospective, Cross-over Study.

Conditions
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COPD, Chronic Respiratory Insufficiency

Intervention / Treatment
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* Device: Free 02


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 85 years COPD patients at the stage of CRF under LTOT or desaturating at exercise Written and signed consent Exclusion Criteria: Patients under guardianship or curatorship. Pregnant women Patients with non-weaned smoking. Patients using technical assistance to move Inability to perform 6MWT due to locomotor disorders. Inability to understand 6MWT due to cognitive disorders Patients exacerbating Unstable angora myocardial infarction < 1 month HR at rest > 120 bpm systolic blood pressure > 18 and/or diastolic blood pressure > 10

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Interventional Model Description: Patients will undergo titration 6 minutes walk test using the standard and the automatic method in random order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual then automated oxygen titration<br>First will be performed the manual oxygen titration and then the automatic oxygen titration. | Device: Free 02<br>* With the manual oxygen titration, the physiotherapist adjust manually the oxygen flow using the FreeO2 device during a titration 6 minutes walk test. With the automated adjustment oxygen titration, the flow will be self adjusted by the FreeO2 device during a titration 6 minutes walk test. In that hase, the median flow rate and the 95th flow rate will be evaluated during the validation 6 minutes walk test.<br>|
| Active Comparator: Automatic then manual oxygen titration<br>First will be performed the automatic oxygen titration and then the manual oxygen titration. | Device: Free 02<br>* With the manual oxygen titration, the physiotherapist adjust manually the oxygen flow using the FreeO2 device during a titration 6 minutes walk test. With the automated adjustment oxygen titration, the flow will be self adjusted by the FreeO2 device during a titration 6 minutes walk test. In that hase, the median flow rate and the 95th flow rate will be evaluated during the validation 6 minutes walk test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in the pulse oxygen saturation target (Sp02) which is 92% +/- 2 during validation 6 minutes walk-test | The time spent will be retrieved from the oxygen delivery device. it will be expressed in percentage of time of the 6 minutes walk tests and seconds. | 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent with moderate hypoxemia (Sp02 <90%), severe hypoxemia (Sp02 <85%) or hyperoxia (Sp02> 94%). | The time spent will be retrieved from the oxygen delivery device. it will be expressed in percentage of time of the 6 minutes walk tests and seconds. | 6 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Long-term oxygen therapy, Six minutes walk test, Exertion, Rehabilitation