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

ADIR Association

Status: Suspended

Conditions: Chronic Respiratory Insufficiency; COPD

Treatments: Device: Free 02

Study type: Interventional

Funder types: Other

Identifiers

NCT04189991

Osixeno

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Manual then automated oxygen titration

Active Comparator group

Description:

First will be performed the manual oxygen titration and then the automatic oxygen titration.

Treatment:

Device: Free 02

Automatic then manual oxygen titration

Active Comparator group

Description:

First will be performed the automatic oxygen titration and then the manual oxygen titration.

Treatment:

Device: Free 02