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

November 13, 2023 updated by: ADIR Association

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • CHU Charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual then automated oxygen titration
First will be performed the manual oxygen titration and then the automatic oxygen titration.
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.
Active Comparator: Automatic then manual oxygen titration
First will be performed the automatic oxygen titration and then the manual oxygen titration.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent in the pulse oxygen saturation target (Sp02) which is 92% +/- 2 during validation 6 minutes walk-test
Time Frame: 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.
6 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent with "moderate hypoxemia" (Sp02 <90%), "severe hypoxemia" (Sp02 <85%) or "hyperoxia" (Sp02> 94%).
Time Frame: 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.
6 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: 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.
Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
Heart rate
Time Frame: 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.
Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
Dyspnoea
Time Frame: 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)
Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
Tiredness of the lower limbs
Time Frame: 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)
Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
Distance walked during the validation 6 minutes walk test
Time Frame: 6 minutes
THe distance will be measured using a metered corridor with a meter precision
6 minutes
Time spent to perform the titrations
Time Frame: 30 minutes
The time spent for each titration procedure will be assessed using a chronometer.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ADIR Association

Investigators

  • Study Chair: Maxime Patout, MD, ADIR Association
  • Principal Investigator: Antoine Cuvelier, PhD, ADIR Association
  • Study Chair: Jean-François Muir, PhD, ADIR Association
  • Study Chair: Pauline Smondack, PT, ADIR Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2020

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Osixeno

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data from the trial will be available upon reasonnable request to the corresponding author. Data will not be made available for any commercial use.

IPD Sharing Time Frame

After study completion and for 10 years.

IPD Sharing Access Criteria

Researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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