Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD

Study Overview
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Brief Summary
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The aim of the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. The investigators hypothesized that continuous automatic adjustment of the oxygen flows during exercise would better maintain patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and with compressed air breathing.

Official Title
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Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD

Conditions
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COPD, Exercise, Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)

Intervention / Treatment
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* Device: Automated oxygen titration
* Drug: Compressed air
* Drug: Oxygen constant flow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 40 years Moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines Who did not require long-term oxygen therapy were included in the study. Patients were also selected on the basis of known (end-exercise SpO2 < 90% on a previous exercise test) or suspected (SpO2 < 95% at rest) desaturation during exercise Exclusion Criteria: Episode of exacerbation or hospitalisation within last four weeks Current medical condition that could influence exercise tolerance

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Compressed Air<br>compressed air delivered at a fixed flow of 2 L/min | Drug: Compressed air<br>* compressed air delivered at a fixed flow of 2 L/min<br>* Other names: Air;|
| Active Comparator: Oxygen constant flow<br>oxygen delivered at a fixed flow of 2L/min | Drug: Oxygen constant flow<br>* oxygen delivered at a fixed flow of 2L/min<br>* Other names: Oxygen;|
| Experimental: Automated oxygen titration<br>oxygen at a variable flows delivered by the FreeO2 | Device: Automated oxygen titration<br>* Automated oxygen titration every second to maintain stable SpO2 at a predefined value (94% in the present study)<br>* Other names: FreeO2 system TM, Oxy'nov.inc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time within predefined SpO2 target | The primary outcome of the study was the percentage of exercise time during which patients were kept within the SpO2 target of 92 to 96% | during exercise (Endurance shuttle walking test) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise tolerance | Endurance shuttle walking test time and distance | duration of ESWT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen therapy, Hypoxemia, COPD, Closed-loop, Automated titration,