Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device
NCT ID: NCT04189991
Last Updated: 2023-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
25 participants
INTERVENTIONAL
2020-02-06
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Manual then automated oxygen titration
First will be performed the manual oxygen titration and then the automatic oxygen titration.
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.
Automatic then manual oxygen titration
First will be performed the automatic oxygen titration and then the manual oxygen titration.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* COPD patients at the stage of CRF under LTOT or desaturating at exercise
* Written and signed consent
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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ADIR Association
OTHER
Responsible Party
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Principal Investigators
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Maxime Patout, MD
Role: STUDY_CHAIR
ADIR Association
Antoine Cuvelier, PhD
Role: PRINCIPAL_INVESTIGATOR
ADIR Association
Jean-François Muir, PhD
Role: STUDY_CHAIR
ADIR Association
Pauline Smondack, PT
Role: STUDY_CHAIR
ADIR Association
Locations
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CHU Charles Nicolle
Rouen, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Commercial description of the device used in the trial
Other Identifiers
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Osixeno
Identifier Type: -
Identifier Source: org_study_id
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