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SuspendedNCT04189991Updated Nov 15, 2023

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

An interventional study of Free 02 in COPD and Chronic Respiratory Insufficiency, sponsored by ADIR Association. Suspended at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by ADIR Association · Not applicable, Interventional, and Treatment

Why this study was suspended
Recruitment has not started yet due to COVID pandemic.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COPD
  • Chronic Respiratory Insufficiency

Keywords

  • COPD
  • Long-term oxygen therapy
  • Six minutes walk test
  • Exertion
  • Rehabilitation
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 25 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

ADIR Association is the lead sponsor of 26 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
25 participants (estimated)

Study arms

  • Active comparator
    Manual then automated oxygen titration

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

    Device: Free 02

  • Active comparator
    Automatic then manual oxygen titration

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

    Device: Free 02

Interventions

  • DeviceFree 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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 6 minutes

Secondary outcomes

  1. Time spent with "moderate hypoxemia" (Sp02 <90%), "severe hypoxemia" (Sp02 <85%) or "hyperoxia" (Sp02> 94%).

    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.

    Time frame: 6 minutes

Other outcomes

  1. Oxygen saturation

    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.

    Time frame: Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.

  2. Heart rate

    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.

    Time frame: Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.

  3. Dyspnoea

    The dyspnea will be assessed using a BORG scale (0: Rest to 10: Maximal)

    Time frame: Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.

  4. Tiredness of the lower limbs

    Tiredness of the lower limbs will be assessed using a visual analogue scale (0: No tiredness at all to 10: Maximal tiredness)

    Time frame: Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.

  5. Distance walked during the validation 6 minutes walk test

    THe distance will be measured using a metered corridor with a meter precision

    Time frame: 6 minutes

  6. Time spent to perform the titrations

    The time spent for each titration procedure will be assessed using a chronometer.

    Time frame: 30 minutes

07

Study locations

1 site
  • CHU Charles Nicolle
    Rouen, 76000, France
08

References and documents

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.
  • Kim V, Benditt JO, Wise RA, Sharafkhaneh A. Oxygen therapy in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2008 May 1;5(4):513-8. doi: 10.1513/pats.200708-124ET. PubMed 18453364 ↗
  • Delample D, Sabate M, Prefaut C, Durand F. Does prior training affect acute O(2) supply responses during exercise in Desaturator COPD patients? Open Respir Med J. 2008;2:29-34. doi: 10.2174/1874306400802010029. Epub 2008 Mar 13. PubMed 19340322 ↗
  • Galera R, Casitas R, Martinez E, Lores V, Rojo B, Carpio C, Llontop C, Garcia-Rio F. Exercise oxygen flow titration methods in COPD patients with respiratory failure. Respir Med. 2012 Nov;106(11):1544-50. doi: 10.1016/j.rmed.2012.06.021. Epub 2012 Jul 21. PubMed 22819520 ↗
  • Ora J, Calzetta L, Pezzuto G, Senis L, Paone G, Mari A, Portalone S, Rogliani P, Puxeddu E, Saltini C. A 6MWT index to predict O2 flow correcting exercise induced SpO2 desaturation in ILD. Respir Med. 2013 Dec;107(12):2014-21. doi: 10.1016/j.rmed.2013.10.002. Epub 2013 Oct 10. PubMed 24161677 ↗
  • Lellouche F, L'her E. Automated oxygen flow titration to maintain constant oxygenation. Respir Care. 2012 Aug;57(8):1254-62. doi: 10.4187/respcare.01343. Epub 2012 Feb 17. PubMed 22348812 ↗
  • Lellouche F, Bouchard PA, Roberge M, Simard S, L'Her E, Maltais F, Lacasse Y. Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial. Int J Chron Obstruct Pulmon Dis. 2016 Aug 24;11:1983-90. doi: 10.2147/COPD.S112820. eCollection 2016. PubMed 27601891 ↗
  • Cirio S, Nava S. Pilot study of a new device to titrate oxygen flow in hypoxic patients on long-term oxygen therapy. Respir Care. 2011 Apr;56(4):429-34. doi: 10.4187/respcare.00983. Epub 2011 Jan 21. PubMed 21255511 ↗
  • Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18. PubMed 27794080 ↗
  • Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pepin JL. Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Thorax. 2019 Mar;74(3):298-301. doi: 10.1136/thoraxjnl-2018-211967. Epub 2018 Aug 30. PubMed 30166425 ↗
  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. doi: 10.1164/rccm.19310erratum. PubMed 12091180 ↗

Individual participant data

Plan to share: Yes — 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 information: Study protocol, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04189991
Lead sponsor
ADIR Association
Responsible party
Sponsor
First posted
Dec 9, 2019
Start date
Feb 6, 2020
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Nov 15, 2023

Study contacts

Maxime Patout, MD
study chair · ADIR Association
Antoine Cuvelier, PhD
principal investigator · ADIR Association
Jean-François Muir, PhD
study chair · ADIR Association
Pauline Smondack, PT
study chair · ADIR Association

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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