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

Primary Purpose

COPD, Chronic Respiratory Insufficiency

Status

Suspended

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Free 02

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Long-term oxygen therapy, Six minutes walk test, Exertion, Rehabilitation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

CHU Charles Nicolle

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Manual then automated oxygen titration

Automatic then manual oxygen titration

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04189991

First Posted

December 5, 2019

Last Updated

February 3, 2023

Sponsor

ADIR Association

1. Study Identification

Unique Protocol Identification Number

NCT04189991

Brief Title

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

Official Title

Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device: a Monocentric, Prospective, Cross-over Study.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Suspended

Why Stopped

Recruitment has not started yet due to COVID pandemic.

Study Start Date

February 6, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ADIR Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Chronic Respiratory Insufficiency

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

Participant

Masking Description

The same device will be used for both oxygen titration protocol and during 6 minutes walk tests.

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Manual then automated oxygen titration

Arm Type

Active Comparator

Arm Description

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

Arm Title

Automatic then manual oxygen titration

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Free 02

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

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

Description

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 Pre-specified Outcome Measures:

Title

Oxygen saturation

Description

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.

Title

Heart rate

Description

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.

Title

Dyspnoea

Description

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.

Title

Tiredness of the lower limbs

Description

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.

Title

Distance walked during the validation 6 minutes walk test

Description

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

Time Frame

6 minutes

Title

Time spent to perform the titrations

Description

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

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maxime Patout, MD

Organizational Affiliation

ADIR Association

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Antoine Cuvelier, PhD

Organizational Affiliation

ADIR Association

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jean-François Muir, PhD

Organizational Affiliation

ADIR Association

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Pauline Smondack, PT

Organizational Affiliation

ADIR Association

Official's Role

Study Chair

Facility Information:

Facility Name

CHU Charles Nicolle

City

Rouen

ZIP/Postal Code

76000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

After study completion and for 10 years.

IPD Sharing Access Criteria

Researchers

Citations:

Citation

Bon usage des technologies de santé, HAS, Oxygénothérapie à long terme : choisir la source la mieux adaptée, Mai 2012.

Results Reference

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Citation

Journal Officiel de la République Française, Arrêté du 23 février 2015, Oxygénothérapie, Février 2015.

Results Reference

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PubMed Identifier

18453364

Citation

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.

Results Reference

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PubMed Identifier

19340322

Citation

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.

Results Reference

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PubMed Identifier

22819520

Citation

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.

Results Reference

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PubMed Identifier

24161677

Citation

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.

Results Reference

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PubMed Identifier

22348812

Citation

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.

Results Reference

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PubMed Identifier

27601891

Citation

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.

Results Reference

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PubMed Identifier

21255511

Citation

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.

Results Reference

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PubMed Identifier

27794080

Citation

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.

Results Reference

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PubMed Identifier

30166425

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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

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