Clinical trial NCT04189991: Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device
Official title: Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device: a Monocentric, Prospective, Cross-over Study.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: COPD
Chronic Respiratory Insufficiency
Keywords: COPD
Long-term oxygen therapy
Six minutes walk test
Exertion
Rehabilitation
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will undergo titration 6 minutes walk test using the standard and the automatic method in random order.
Primary purpose: TREATMENT

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.

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
* systolic blood pressure \> 18 and/or diastolic blood pressure \> 10

Primary outcomes:
measure: Time spent in the pulse oxygen saturation target (Sp02) which is 92% +/- 2 during validation 6 minutes walk-test
timeFrame: 6 minutes
Secondary outcomes:
measure: Time spent with "moderate hypoxemia" (Sp02 <90%), "severe hypoxemia" (Sp02 <85%) or "hyperoxia" (Sp02> 94%).
timeFrame: 6 minutes
Other outcomes:
measure: Oxygen saturation
timeFrame: Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
measure: Heart rate
timeFrame: Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
measure: Dyspnoea
timeFrame: Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
measure: Tiredness of the lower limbs
timeFrame: Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
measure: Distance walked during the validation 6 minutes walk test
timeFrame: 6 minutes
measure: Time spent to perform the titrations
timeFrame: 30 minutes
Locations:
city: Rouen
country: France
facility: CHU Charles Nicolle
Study officials:
affiliation: ADIR Association
name: Maxime Patout, MD
role: STUDY_CHAIR
affiliation: ADIR Association
name: Antoine Cuvelier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ADIR Association
name: Jean-François Muir, PhD
role: STUDY_CHAIR
affiliation: ADIR Association
name: Pauline Smondack, PT
role: STUDY_CHAIR
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