COPDNCT04189991
Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device
A study testing Free 02 in people with COPD and Chronic Respiratory Insufficiency, run by ADIR Association at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COPD, Chronic Respiratory Insufficiency
- What is being tested?
- Free 02
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 85 years
- COPD patients at the stage of CRF under LTOT or desaturating at exercise
- Written and signed consent
Who cannot join
- 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
Show all 11Show fewer
- Patients exacerbating
- Unstable angora
- myocardial infarction < 1 month
- HR at rest > 120 bpm
- systolic blood pressure > 18 and/or diastolic blood pressure > 10
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device: a Monocentric, Prospective, Cross-over Study.
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.
Read the 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.
- Conditions
- COPD, Chronic Respiratory Insufficiency
- Being tested
- Free 02
- Keywords
- COPD, Long-term oxygen therapy, Six minutes walk test, Exertion, Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free 02Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual then automated oxygen titration | Active comparator | First will be performed the manual oxygen titration and then the automatic oxygen titration. Receives: Device: Free 02 |
| Automatic then manual oxygen titration | Active comparator | First will be performed the automatic oxygen titration and then the manual oxygen titration. Receives: Device: Free 02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 minutes
Secondary outcomes (1)
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.
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start6 Feb 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Recruitment has not started yet due to COVID pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will undergo titration 6 minutes walk test using the standard and the automatic method in random order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Patout, MD, Study chair, ADIR AssociationAntoine Cuvelier, PhD, Principal investigator, ADIR AssociationJean-François Muir, PhD, Study chair, ADIR AssociationPauline Smondack, PT, Study chair, ADIR Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189991
- Sponsor's protocol ID
- Osixeno
- Status last verified
- Nov 2023
- First submitted
- 5 Dec 2019
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 18453364Delample 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.
PubMed 19340322Galera 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.
PubMed 22819520Ora 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.
PubMed 24161677Lellouche 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.
PubMed 22348812Lellouche 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.
PubMed 27601891Cirio 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.
PubMed 21255511Lellouche 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.
PubMed 27794080Vivodtzev 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.
PubMed 30166425ATS 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.
PubMed 12091180
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Titration Protocol for Exertion of COPD Patients by an Automated Adjustment Device: a Monocentric, Prospective, Cross-over Study.
- ClinicalTrials.gov ID
- NCT04189991
- Acronym / sponsor ID
- Osixeno
- Conditions
- COPD, Chronic Respiratory Insufficiency
- Keywords
- COPD, Long-term oxygen therapy, Six minutes walk test, Exertion, Rehabilitation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment has not started yet due to COVID pandemic.
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will undergo titration 6 minutes walk test using the standard and the automatic method in random order.
| Arm | Type | Receives |
|---|---|---|
| Manual then automated oxygen titration | Active comparator | Device: Free 02First will be performed the manual oxygen titration and then the automatic oxygen titration. |
| Automatic then manual oxygen titration | Active comparator | Device: Free 02First will be performed the automatic oxygen titration and then the manual oxygen titration. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 85 years
- COPD patients at the stage of CRF under LTOT or desaturating at exercise
- Written and signed consent
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free 02With 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. | Device | Automatic then manual oxygen titration, Manual then automated oxygen titration |
Primary outcome
Time spent in the pulse oxygen saturation target (Sp02) which is 92% +/- 2 during validation 6 minutes walk-test
Time frame: 6 minutes
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.
1 secondary outcome
Time spent with "moderate hypoxemia" (Sp02 <90%), "severe hypoxemia" (Sp02 <85%) or "hyperoxia" (Sp02> 94%).
Time frame: 6 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- BackgroundBon usage des technologies de santé, HAS, Oxygénothérapie à long terme : choisir la source la mieux adaptée, Mai 2012.
- BackgroundJournal Officiel de la République Française, Arrêté du 23 février 2015, Oxygénothérapie, Février 2015.
- Background: PubMed 18453364Kim 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.
- Background: PubMed 19340322Delample 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.
- Background: PubMed 22819520Galera 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.
- Background: PubMed 24161677Ora 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.
- Background: PubMed 22348812Lellouche 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.
- Background: PubMed 27601891Lellouche 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.
- Background: PubMed 21255511Cirio 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.
- Background: PubMed 27794080Lellouche 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.
- Background: PubMed 30166425Vivodtzev 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.
- Background: PubMed 12091180ATS 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.
- Commercial description of the device used in the trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Patout, MD study chair
ADIR Association
Antoine Cuvelier, PhD principal investigator
ADIR Association
Jean-François Muir, PhD study chair
ADIR Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free 02 in people with COPD and Chronic Respiratory Insufficiency, run by ADIR Association at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in the pulse oxygen saturation target (Sp02) which is 92% +/- 2 during validation 6 minutes walk-test (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04189991, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.