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Recruitment has not started yet due to COVID pandemic.
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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.
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:
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:
During validation 6 minutes walk test, oxygen saturation, dyspnea, walked distance and heart rate will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual then automated oxygen titration | Active Comparator | First will be performed the manual oxygen titration and then the automatic oxygen titration. |
|
| Automatic then manual oxygen titration | Active Comparator | First will be performed the automatic oxygen titration and then the manual oxygen titration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free 02 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before, after the 6MWT, 1 minute after the end of the 6MWT, 3 minutes, 6 minutes, 10 minutes. |
| Heart rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maxime Patout, MD | ADIR Association | Study Chair |
| Antoine Cuvelier, PhD | ADIR Association | Principal Investigator |
| Jean-François Muir, PhD | ADIR Association | Study Chair |
| Pauline Smondack, PT | ADIR Association | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Charles Nicolle | Rouen | 76000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bon usage des technologies de santé, HAS, Oxygénothérapie à long terme : choisir la source la mieux adaptée, Mai 2012. | ||
| Background | Journal Officiel de la République Française, Arrêté du 23 février 2015, Oxygénothérapie, Février 2015. | ||
| 18453364 | Background | 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. | |
| 19340322 |
| Label | URL |
|---|---|
| Commercial description of the device used in the trial | View source |
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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.
After study completion and for 10 years.
Researchers
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Patients will undergo titration 6 minutes walk test using the standard and the automatic method in random order.
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The same device will be used for both oxygen titration protocol and during 6 minutes walk tests.
|
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 | 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 | 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 | THe distance will be measured using a metered corridor with a meter precision | 6 minutes |
| Time spent to perform the titrations | The time spent for each titration procedure will be assessed using a chronometer. | 30 minutes |
| Background |
| 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. |
| 22819520 | Background | 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. |
| 24161677 | Background | 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. |
| 22348812 | Background | 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. |
| 27601891 | Background | 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. |
| 21255511 | Background | 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. |
| 27794080 | Background | 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. |
| 30166425 | Background | 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. |
| 12091180 | Background | 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |