Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device: a Monocentric, Prospective, Cross-over Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- ADIR Association
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Time spent in the pulse oxygen saturation target (Sp02) which is 92% +/- 2 during validation 6 minutes walk-test
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time spent in the pulse oxygen saturation target (Sp02) which is 92% +/- 2 during validation 6 minutes walk-test
Time Frame: 6 minutes
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.
Secondary Outcomes
- Time spent with "moderate hypoxemia" (Sp02 <90%), "severe hypoxemia" (Sp02 <85%) or "hyperoxia" (Sp02> 94%).(6 minutes)