COPD ExacerbationNCT01393015
Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With COPD Exacerbation
A study testing Automated settings on the oxygen delivery device and Manual settings with FreeO2 system in collection mode in people with COPD Exacerbation, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
Trial summary
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen and to enable a remote medical monitoring with a homogeneous patient population hospitalize for Chronic obstructive pulmonary disease (COPD)exacerbation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation
- 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
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Dec 2011
- 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
- Patient hospitalized for COPD exacerbation
- 40 Years and older
- Former or current smoker greater than or equal to 10 pack-years
- Suspicion or diagnosis of COPD at the hospitalisation
- Acute dyspnea or acute aggravation of dyspnea
- Respiratory rate greater than or equal to 20 breaths/min
- Patient needs an oxygen therapy by nasal cannula with oxygen delivered between 0.5 to 8L/min to hold SpO2 greater than or equal to 92%
Who cannot join
- Imminent indications for intubation
- FreeO2 system is unavailable at the moment of randomization
- Patient in isolation (barrier nursing) to the inclusion
- Patient participates to another clinical trial without possibility of co-enrollment
- Patient with diagnosis of sleep apnea
Trial locations and contacts
1 site in 1 country.
Maude Roberge contact
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche de l'institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
Pierre-Alexandre Bouchard, inh, 1-418-656-8711 ext. 2712, pierre-alexandre.bouchard.1@ulaval.ca
Maude Roberge, maude.roberge.1@ulaval.ca
About this study
Official title: Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With Exacerbations of Chronic Obstructive Pulmonary Disease.
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen and to enable a remote medical monitoring with a homogeneous patient population hospitalize for Chronic obstructive pulmonary disease (COPD)exacerbation.
Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel and to improve the support with centralized monitoring in the FreeO2 group.
- Conditions
- COPD Exacerbation
- Being tested
- Automated settings on the oxygen delivery device, Manual settings with FreeO2 system in collection mode
- Keywords
- automatic, automation, oxygen, weaning, COPD, exacerbation
- 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.
Automated settings on the oxygen delivery deviceDevice
FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal. Patients keep using the same device for duration of hospitalization.
Manual settings with FreeO2 system in collection modeDevice
Oxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| FreeO2 system | Experimental | FreeO2 is a new system that automatically adjusts the oxygen flow delivered to patients in 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 |
| Rotameter (flowmeter) | Active comparator | A rotameter is a device that measures the flow rate of liquid or gas in a closed tube. Receives: Device: Manual settings with FreeO2 system in collection mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Possibility to use a new closed-loop system for oxygen delivery in common practice
We will see if nurses and medical personnel are agree to work with FreeO2 system. We want to know if the new system of automated adjustment of oxygen flow is useful in common practice.
Measured: 6 months
Secondary outcomes (3)
Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2.
Measured: 6 months
Percentage of time with desaturation during the oxygentherapy
Measured: 6 months
Percentage of time with hyperoxia during the oxygentherapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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 COPD ExacerbationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Investigators
- François Lellouche, Md, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393015
- Sponsor's protocol ID
- FreeO2-COPD-5ePC
- Status last verified
- May 2011
- First submitted
- 11 Jul 2011
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Poder TG, Kouakou CRC, Bouchard PA, Tremblay V, Blais S, Maltais F, Lellouche F. Cost-effectiveness of FreeO2 in patients with chronic obstructive pulmonary disease hospitalised for acute exacerbations: analysis of a pilot study in Quebec. BMJ Open. 2018 Jan 23;8(1):e018835. doi: 10.1136/bmjopen-2017-018835.
PubMed 29362258
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. 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 Oxygentherapy in Patients With Exacerbations of Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT01393015
- Acronym / sponsor ID
- FreeO2-COPD-5ePC
- Conditions
- COPD Exacerbation
- Keywords
- automatic, automation, oxygen, weaning, COPD, exacerbation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 13 Jul 2011 (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.
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen and to enable a remote medical monitoring with a homogeneous patient population hospitalize for Chronic obstructive pulmonary disease (COPD)exacerbation.
Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel and to improve the support with centralized monitoring in the FreeO2 group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 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. |
| Rotameter (flowmeter) | Active comparator | Device: Manual settings with FreeO2 system in collection modeA rotameter is a device that measures the flow rate of liquid or gas in a closed tube. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient hospitalized for COPD exacerbation
- 40 Years and older
- Former or current smoker greater than or equal to 10 pack-years
- Suspicion or diagnosis of COPD at the hospitalisation
- Acute dyspnea or acute aggravation of dyspnea
Key exclusion criteria (5 listed)
- Imminent indications for intubation
- FreeO2 system is unavailable at the moment of randomization
- Patient in isolation (barrier nursing) to the inclusion
- Patient participates to another clinical trial without possibility of co-enrollment
- Patient with diagnosis of sleep apnea
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. Patients keep using the same device for duration of hospitalization. | Device | FreeO2 system |
| Manual settings with FreeO2 system in collection modeOxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization. | Device | Rotameter (flowmeter) |
Primary outcome
Possibility to use a new closed-loop system for oxygen delivery in common practice
Time frame: 6 months
We will see if nurses and medical personnel are agree to work with FreeO2 system. We want to know if the new system of automated adjustment of oxygen flow is useful in common practice.
3 secondary outcomes
Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2.
Time frame: 6 months
Percentage of time with desaturation during the oxygentherapy
Time frame: 6 months
Percentage of time with hyperoxia during the oxygentherapy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
- Derived from this study: PubMed 29362258Poder TG, Kouakou CRC, Bouchard PA, Tremblay V, Blais S, Maltais F, Lellouche F. Cost-effectiveness of FreeO2 in patients with chronic obstructive pulmonary disease hospitalised for acute exacerbations: analysis of a pilot study in Quebec. BMJ Open. 2018 Jan 23;8(1):e018835. doi: 10.1136/bmjopen-2017-018835.
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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.
Maude Roberge contact
François Lellouche, Md principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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 settings on the oxygen delivery device and Manual settings with FreeO2 system in collection mode in people with COPD Exacerbation, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Jul 2011. 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. 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?
Contact Pierre-Alexandre Bouchard, inh (1 418 656-8711 ext. 2712, pierre-alexandre.bouchard.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Possibility to use a new closed-loop system for oxygen delivery in common practice (time frame: 6 months). 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 NCT01393015, 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 13 Jul 2011; AzTrials last refreshed its copy on 27 Oct 2026.