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

Not Applicable

Suspended

• Conditions: COPD; Chronic Respiratory Insufficiency

• Registration Number: NCT04189991
• Lead Sponsor: ADIR Association

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.

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Study Start: 2020-02-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU Charles Nicolle; 🇫🇷 Rouen, France