COPDFreeO2-rehabNCT01575327
Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease
A study testing Automated settings on the oxygen delivery device and Manual settings with FreeO2 system in collection mode in people with COPD and Oxygen Therapy, run by AGIR à Dom at 3 sites in France.
Trial summary
The purpose of this study is to investigate the benefit of Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test in patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and hypercapnia. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Oxygen Therapy, Hypercapnia
- What is being tested?
- Automated settings on the oxygen delivery device and Manual settings with FreeO2 system in collection mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesFrance
- Study dates
- Jul 2012to Jun 2016
- 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
- 40 Years and older
- Patient with COPD severe to very severe requiring long-term Oxygen Therapy
- Hypercapnia (PaCO2 > 45mmHg)
- Former or current smoker greater than or equal to 10 pack-years
Who cannot join
- Pregnant or breast-feed woman
- Patients under guardianship
- Imprisoned patients
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital Universitaire
Grenoble
Centre ATRIR
Nyons, 26110
Centre Henri BAZIRE
Saint-Julien-de-Raz, 38134
About this study
Official title: Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Exercise Tolerance During Walk in Patients With COPD, Oxygen Therapy and Hypercapnia
The purpose of this study is to investigate the benefit of Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test in patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and hypercapnia.
The study was designed to test the following hypotheses:
Read more
As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to higher exercise tolerance (distance during ESWT) and lower desaturation events without increase in hypercapnia in patients with COPD, oxygen therapy and hypercapnia.
As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower dyspnea and leg fatigue scores at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.
As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower cardiac and respiratory frequencies at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.
Read the detailed description
Background:
In spite of oxygen therapy, desaturations frequently occur during exercise in COPD patients. Although current recommendations are to add 1 L/min to the baseline oxygen flow during exertion, a new closed-loop system (FreeO2) automatically and continuously adjusts the oxygen flow to the patient's needs based on the oxygen saturation by pulse oximetry (SpO2), end-tidal CO2 (EtCO2) and respiratory rate. A preliminary study showed significant improvement in exercise tolerance in COPD patients not needing oxygen therapy. Although oxygen flow could be two fold increased during exercise, a worsening hypercapnia is plausible in severe COPD.
Aim of this study is to evaluate this system during endurance shuttle walking test in COPD patients with oxygen therapy and hypercapnia.
Methods: The investigators proposed to conduct a controlled, randomized cross-over study comparing the efficacy of a Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during an endurance shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.
- Conditions
- COPD, Oxygen Therapy, Hypercapnia
- Being tested
- Automated settings on the oxygen delivery device, Manual settings with FreeO2 system in collection mode
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated settings on the oxygen delivery deviceDevice
FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal and collects the cardiorespiratory parameters
Manual settings with FreeO2 system in collection modeDevice
FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters
| Study group | Role | What they receive |
|---|---|---|
| Fixed oxygen flow delivery | Active comparator | Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment. Receives: Device: Manual settings with FreeO2 system in collection mode |
| FreeO2 system | Experimental | FreeO2 is a new system that automatically adjusts the oxygen flow delivered to patients in a closed-loop based on the SpO2 signal. This system is intended to maintain SpO2 in a predefined target and to adapt oxygen flow to patient's needs. Receives: Device: Automated settings on the oxygen delivery device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endurance time
Duration during the endurance shuttle walking test
Measured: Day 0 (inclusion) + 14 and D0 +21
Secondary outcomes (7)
Change in Dyspnea during ESWT
Visual analogic scores of dyspnea during the endurance shuttle walking test
Measured: Day 0 (inclusion) + 14 and D0 +21
Change in Muscle fatigue during ESWT
Visual analogic scores of leg discomfort during the endurance shuttle walking test
Measured: Day 0 (inclusion) + 14 and D0 +21
Change in Respiratory frequency during ESWT
Respiratory frequency measurement by the FreeO2 system during the endurance shuttle walking test
Measured: Day 0 (inclusion) + 14 and D0 +21
Change in PaCO2 during ESWT
EtCO2 measurement by the FreeO2 system during the endurance shuttle walking test
Measured: Day 0 (inclusion) + 14 and D0 +21
Hypercapnia level at baseline
Blood gases at rest
Measured: Day 0 (inclusion) - baseline evaluation
Change in Cardiac frequency during ESWT
Cardiac frequency measurement by the FreeO2 system during the endurance shuttle walking test
Measured: Day 0 (inclusion) + 14 and D0 +21
Change in SpO2 during ESWT
Pulse oxygen saturation during the endurance shuttle walking test
Measured: Day 0 (inclusion) + 14 and D0 +21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2016
- Study completionJun 2016
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pepin, MD, PhD, Principal investigator, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575327
- Sponsor's protocol ID
- 11-AGIR-01
- Acronym
- FreeO2-rehab
- Status last verified
- Jan 2017
- First submitted
- 13 Mar 2012
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30166425
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Exercise Tolerance During Walk in Patients With COPD, Oxygen Therapy and Hypercapnia
- ClinicalTrials.gov ID
- NCT01575327
- Acronym / sponsor ID
- FreeO2-rehab / 11-AGIR-01
- Conditions
- COPD, Oxygen Therapy, Hypercapnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble
- Study start
- Jul 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Apr 2012 (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 purpose of this study is to investigate the benefit of Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test in patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and hypercapnia.
The study was designed to test the following hypotheses:
As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to higher exercise tolerance (distance during ESWT) and lower desaturation events without increase in hypercapnia in patients with COPD, oxygen therapy and hypercapnia.
As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower dyspnea and leg fatigue scores at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.
As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower cardiac and respiratory frequencies at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.
Detailed description
Background:
In spite of oxygen therapy, desaturations frequently occur during exercise in COPD patients. Although current recommendations are to add 1 L/min to the baseline oxygen flow during exertion, a new closed-loop system (FreeO2) automatically and continuously adjusts the oxygen flow to the patient's needs based on the oxygen saturation by pulse oximetry (SpO2), end-tidal CO2 (EtCO2) and respiratory rate. A preliminary study showed significant improvement in exercise tolerance in COPD patients not needing oxygen therapy. Although oxygen flow could be two fold increased during exercise, a worsening hypercapnia is plausible in severe COPD.
Aim of this study is to evaluate this system during endurance shuttle walking test in COPD patients with oxygen therapy and hypercapnia.
Methods: The investigators proposed to conduct a controlled, randomized cross-over study comparing the efficacy of a Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during an endurance shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed oxygen flow delivery | Active comparator | Device: Manual settings with FreeO2 system in collection modeOxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment. |
| FreeO2 system | Experimental | Device: Automated settings on the oxygen delivery deviceFreeO2 is a new system that automatically adjusts the oxygen flow delivered to patients in a closed-loop based on the SpO2 signal. This system is intended to maintain SpO2 in a predefined target and to adapt oxygen flow to patient's needs. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40 Years and older
- Patient with COPD severe to very severe requiring long-term Oxygen Therapy
- Hypercapnia (PaCO2 > 45mmHg)
- Former or current smoker greater than or equal to 10 pack-years
Key exclusion criteria (3 listed)
- Pregnant or breast-feed woman
- Patients under guardianship
- Imprisoned patients
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 settings on the oxygen delivery deviceFreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal and collects the cardiorespiratory parameters | Device | FreeO2 system |
| Manual settings with FreeO2 system in collection modeFreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters | Device | Fixed oxygen flow delivery |
Primary outcome
Change in Endurance time
Time frame: Day 0 (inclusion) + 14 and D0 +21
Duration during the endurance shuttle walking test
7 secondary outcomes
Change in Dyspnea during ESWT
Time frame: Day 0 (inclusion) + 14 and D0 +21
Change in Muscle fatigue during ESWT
Time frame: Day 0 (inclusion) + 14 and D0 +21
Change in Respiratory frequency during ESWT
Time frame: Day 0 (inclusion) + 14 and D0 +21
Change in PaCO2 during ESWT
Time frame: Day 0 (inclusion) + 14 and D0 +21
Hypercapnia level at baseline
Time frame: Day 0 (inclusion) - baseline evaluation
Change in Cardiac frequency during ESWT
Time frame: Day 0 (inclusion) + 14 and D0 +21
Change in SpO2 during ESWT
Time frame: Day 0 (inclusion) + 14 and D0 +21
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 14 Mar 2018.
- Derived from this study: 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.
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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.
Jean-Louis Pepin, MD, PhD principal investigator
Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated settings on the oxygen delivery device and Manual settings with FreeO2 system in collection mode in people with COPD and Oxygen Therapy, run by AGIR à Dom at 3 sites 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 4 inclusion and 3 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Change in Endurance time (time frame: Day 0 (inclusion) + 14 and D0 +21). 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 NCT01575327, 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 14 Mar 2018.