Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04189991
Recruitment Status : Suspended (Recruitment has not started yet due to COVID pandemic.)
First Posted : December 9, 2019
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COPD Chronic Respiratory Insufficiency Device: Free 02 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients will undergo titration 6 minutes walk test using the standard and the automatic method in random order.
Masking: Single (Participant)
Masking Description: The same device will be used for both oxygen titration protocol and during 6 minutes walk tests.
Primary Purpose: Treatment
Official Title: Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device: a Monocentric, Prospective, Cross-over Study.
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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)

  4. 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)

  5. 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. Time spent to perform the titrations [ Time Frame: 30 minutes ]
    The time spent for each titration procedure will be assessed using a chronometer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189991


Locations
Layout table for location information
France
CHU Charles Nicolle
Rouen, France, 76000
Sponsors and Collaborators
ADIR Association
Investigators
Layout table for investigator information
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
Additional Information:
Publications:
Bon usage des technologies de santé, HAS, Oxygénothérapie à long terme : choisir la source la mieux adaptée, Mai 2012.
Journal Officiel de la République Française, Arrêté du 23 février 2015, Oxygénothérapie, Février 2015.

Layout table for additonal information
Responsible Party: ADIR Association
ClinicalTrials.gov Identifier: NCT04189991    
Other Study ID Numbers: Osixeno
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After study completion and for 10 years.
Access Criteria: Researchers

Layout table for additional information
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
Keywords provided by ADIR Association:
COPD
Long-term oxygen therapy
Six minutes walk test
Exertion
Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases