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

NCT04189991 | Suspended

• 1 other identifier: Osixeno
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Chronic Respiratory Insufficiency

Keywords

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

Outcome Measures

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.

  6 minutes

Secondary Outcomes (1)

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

  6 minutes

Other Outcomes (6)

• 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.

Study Arms (2)

Manual then automated oxygen titration

ACTIVE COMPARATOR

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

Device: Free 02

Automatic then manual oxygen titration

ACTIVE COMPARATOR

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

Device: Free 02

Interventions

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.

Automatic then manual oxygen titration; Manual then automated oxygen titration

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 85 years
• COPD patients at the stage of CRF under LTOT or desaturating at exercise
• Written and signed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

CHU Charles Nicolle

Rouen, 76000, France

Location

Related Publications (12)

• 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.

  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.

  PMID: 18453364 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.

  PMID: 19340322 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.

  PMID: 22819520 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.

  PMID: 24161677 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.

  PMID: 22348812 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.

  PMID: 27601891 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.

  PMID: 21255511 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.

  PMID: 27794080 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.

  PMID: 30166425 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.

  PMID: 12091180 BACKGROUND

Related Links

• Commercial description of the device used in the trial

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The same device will be used for both oxygen titration protocol and during 6 minutes walk tests.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will undergo titration 6 minutes walk test using the standard and the automatic method in random order.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: February 6, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After study completion and for 10 years.
• Access Criteria: Researchers

Locations

FR (1)