NCT04189991

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

Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device: a Monocentric, Prospective, Cross-over Study.

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: ADIR Association · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• Chronic Respiratory Insufficiency

Interventions

Type	Name	Description
DEVICE	Free 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.

Timeline

• Start date: 2020-02-06
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-12-09
• Last updated: 2023-11-15

Locations

1 site across 1 country: France