Chronic Respiratory Insufficiency, COPD
Conditions
Keywords
COPD, Long-term oxygen therapy, Six minutes walk test, Exertion, Rehabilitation
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.
Interventions
DEVICEFree 02
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.
Sponsors
ADIR Association
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The same device will be used for both oxygen titration protocol and during 6 minutes walk tests.
Intervention model description
Patients will undergo titration 6 minutes walk test using the standard and the automatic method in random order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in the pulse oxygen saturation target (Sp02) which is 92% +/- 2 during validation 6 minutes walk-test | 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
| Measure | Time frame | Description |
|---|---|---|
| Time spent with moderate hypoxemia (Sp02 <90%), severe hypoxemia (Sp02 <85%) or hyperoxia (Sp02> 94%). | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dyspnoea | Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes. | The dyspnea will be assessed using a BORG scale (0: Rest to 10: Maximal) |
| Tiredness of the lower limbs | Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes. | Tiredness of the lower limbs will be assessed using a visual analogue scale (0: No tiredness at all to 10: Maximal tiredness) |
| Oxygen saturation | Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes. | The oxygen saturation will be retrieved from the oxygen delivery device. it will be expressed in percentage of time of the 6 minutes walk tests and seconds. |
| Time spent to perform the titrations | 30 minutes | The time spent for each titration procedure will be assessed using a chronometer. |
| Distance walked during the validation 6 minutes walk test | 6 minutes | THe distance will be measured using a metered corridor with a meter precision |
| Heart rate | Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes. | The heart rate will be retrieved from the oxygen delivery device. it will be expressed in percentage of time of the 6 minutes walk tests and seconds. |
Countries
France
Outcome results
None listed