NCT04189991|Suspended
Study Stopped
Recruitment has not started yet due to COVID pandemic.
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Recruitment has not started yet due to COVID pandemic.
Sponsor study identifier
interventional
25
1 country
1
Study Start
February 6, 2020
Actual (reported)Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 5, 2019
Actual (reported)December 9, 2019
Actual (reported)February 6, 2020
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
6 minutes
Time spent with "moderate hypoxemia" (Sp02 <90%), "severe hypoxemia" (Sp02 <85%) or "hyperoxia" (Sp02> 94%).
6 minutes
Oxygen saturation
Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
Heart rate
Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
Dyspnoea
Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes.
First will be performed the manual oxygen titration and then the automatic oxygen titration.
First will be performed the automatic oxygen titration and then the manual oxygen titration.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CHU Charles Nicolle
Rouen, 76000, France
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.
Maxime Patout, MD
ADIR Association
Antoine Cuvelier, PhD
ADIR Association
Jean-François Muir, PhD
ADIR Association
Pauline Smondack, PT
ADIR Association
First Submitted
December 5, 2019
First Posted
December 9, 2019
Study Start
February 6, 2020
Actual (reported)Contact the study team to confirm eligibility.
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.
Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 15, 2023
Record last verified: 2023-11
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.
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Source: ClinicalTrials.gov.
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