COPDFreeO2rehabNCT02150434
Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD
A study testing Automated oxygen titration, Compressed air and Oxygen constant flow in people with COPD and Exercise, run by Laval University at 1 site in Canada.
Trial summary
The aim of the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Exercise, Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)
- What is being tested?
- Automated oxygen titration, Compressed air and Oxygen constant flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Jun 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 40 years
- Moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
- Who did not require long-term oxygen therapy were included in the study.
- Patients were also selected on the basis of known (end-exercise SpO2 < 90% on a previous exercise test) or suspected (SpO2 < 95% at rest) desaturation during exercise
Who cannot join
- Episode of exacerbation or hospitalisation within last four weeks
- Current medical condition that could influence exercise tolerance
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. The investigators hypothesized that continuous automatic adjustment of the oxygen flows during exercise would better maintain patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and with compressed air breathing.
- Conditions
- COPD, Exercise, Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)
- Being tested
- Automated oxygen titration, Compressed air, Oxygen constant flow
- Keywords
- Oxygen therapy, Hypoxemia, COPD, Closed-loop, Automated titration,
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated oxygen titrationDevice
Also called FreeO2 system TM, Oxy'nov.inc
Automated oxygen titration every second to maintain stable SpO2 at a predefined value (94% in the present study)
Compressed airDrug
Also called Air
compressed air delivered at a fixed flow of 2 L/min
Oxygen constant flowDrug
Also called Oxygen
oxygen delivered at a fixed flow of 2L/min
| Study group | Role | What they receive |
|---|---|---|
| Compressed Air | Sham comparator | compressed air delivered at a fixed flow of 2 L/min Receives: Drug: Compressed air |
| Oxygen constant flow | Active comparator | oxygen delivered at a fixed flow of 2L/min Receives: Drug: Oxygen constant flow |
| Automated oxygen titration | Experimental | oxygen at a variable flows delivered by the FreeO2 Receives: Device: Automated oxygen titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time within predefined SpO2 target
The primary outcome of the study was the percentage of exercise time during which patients were kept within the SpO2 target of 92 to 96%
Measured: during exercise (Endurance shuttle walking test)
Secondary outcomes (1)
Exercise tolerance
Endurance shuttle walking test time and distance
Measured: duration of ESWT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Canada Foundation for Innovation
- Responsible party
- Sponsor
- Investigators
- François Lellouche, MD PhD, Principal investigator, Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150434
- Sponsor's protocol ID
- FreeO2-Rehab-1
- Acronym
- FreeO2rehab
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27794080
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD
- ClinicalTrials.gov ID
- NCT02150434
- Acronym / sponsor ID
- FreeO2rehab / FreeO2-Rehab-1
- Conditions
- COPD, Exercise, Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)
- Keywords
- Oxygen therapy, Hypoxemia, COPD, Closed-loop, Automated titration,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Canada Foundation for Innovation
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 May 2014 (estimated)
- 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 the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. The investigators hypothesized that continuous automatic adjustment of the oxygen flows during exercise would better maintain patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and with compressed air breathing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Compressed Air | Sham comparator | Drug: Compressed aircompressed air delivered at a fixed flow of 2 L/min |
| Oxygen constant flow | Active comparator | Drug: Oxygen constant flowoxygen delivered at a fixed flow of 2L/min |
| Automated oxygen titration | Experimental | Device: Automated oxygen titrationoxygen at a variable flows delivered by the FreeO2 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 40 years
- Moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
- Who did not require long-term oxygen therapy were included in the study.
- Patients were also selected on the basis of known (end-exercise SpO2 < 90% on a previous exercise test) or suspected (SpO2 < 95% at rest) desaturation during exercise
Key exclusion criteria (2 listed)
- Episode of exacerbation or hospitalisation within last four weeks
- Current medical condition that could influence exercise tolerance
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 |
|---|---|---|
| Automated oxygen titrationAlso: FreeO2 system TM, Oxy'nov.incAutomated oxygen titration every second to maintain stable SpO2 at a predefined value (94% in the present study) | Device | Automated oxygen titration |
| Compressed airAlso: Aircompressed air delivered at a fixed flow of 2 L/min | Drug | Compressed Air |
| Oxygen constant flowAlso: Oxygenoxygen delivered at a fixed flow of 2L/min | Drug | Oxygen constant flow |
Primary outcome
Time within predefined SpO2 target
Time frame: during exercise (Endurance shuttle walking test)
The primary outcome of the study was the percentage of exercise time during which patients were kept within the SpO2 target of 92 to 96%
1 secondary outcome
Exercise tolerance
Time frame: duration of ESWT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Derived from this study: 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.
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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.
François Lellouche, MD PhD principal investigator
Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated oxygen titration, Compressed air and Oxygen constant flow in people with COPD and Exercise, run by Laval University at 1 site in Canada.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 29 May 2014. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 within predefined SpO2 target (time frame: during exercise (Endurance shuttle walking test)). 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 NCT02150434, which also lists 1 linked publication.
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 29 May 2014.