Oxygen ToxicityFreeO2 HypHopNCT03835741
Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop
A study testing FreeO2 and manual titration in people with Oxygen Toxicity and COPD Exacerbation, run by Laval University at 1 site in Canada.
Trial summary
The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Toxicity, COPD Exacerbation, Hyperoxia
- What is being tested?
- FreeO2 and manual titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2018to 12 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD or suspected COPD ( Age>40, active or smoking history > 10pack/years), -
- Acute exacerbation (increasing dyspnea recently)
- One or more of the following criteria: increased sputum, modification of sputum purulence,increased dyspnea,
- Moderate oxygen therapy: Oxygen flow < 8 lpm (or FiO2 < 0.60) to maintain a SpO2 >or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 > or = 92%)
Who cannot join
- Patient refusal
- COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose
- No SpO2 signal
- Encephalopathy score > 2
- Delirium
- Other respiratory support needed (intubation or NIV)
Show all 10Show fewer
- Patient on withdrawal life support
- Advance neoplasia (palliative stage) or terminal respiratory distress
- Unavailability of FreeO2 device at the randomisation
- Non optimal patient collaboration
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V4G5
About this study
Official title: Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop
The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.
Read the detailed description
The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.
Patients with severe acute exacerbation of COPD requiring hospitalization will be included in this randomized controlled study and will be managed with either manual oxygen titration or automated oxygen titration (FreeO2 arm).
The impact on the hospital length of stay will be evaluated.
- Being tested
- FreeO2, manual titration
- Medical subject headings
- Hyperoxia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeO2Device
an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
manual titrationOther
a manual adjustment of oxygen during patient hospitalisation by hospital staff
| Study group | Role | What they receive |
|---|---|---|
| Automated Oxygen titration | Experimental | In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device Receives: Device: FreeO2 |
| Manual Oxygen titration | Other | In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff Receives: Other: manual titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Duration of the hospital length of stay
Measured: From hospital admission until hospital discharge (around one week expected)
Secondary outcomes (3)
ICU transfer
The rate of ICU admission during hospital stay
Measured: During hospital stay : from hospital admission until hospital discharge (around one week expected)
Oxygen administration duration
The number of days patient receive oxygen supplementation
Measured: During hospital stay : from hospital admission until hospital discharge (around one week expected)
Non invasive or invasive mechanic ventilation rate use
The rate of NIV use during length of stay in hospital
Measured: During hospital stay: from hospital admission until hospital discharge (around one week expected)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start17 Dec 2018
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Why it stopped: The clinical implementation of the system used in the study as well as its routine use limited the possibilities of carrying out this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ToxicityStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835741
- Sponsor's protocol ID
- 21641
- Acronym
- FreeO2 HypHop
- Status last verified
- Aug 2025
- First submitted
- 14 Jan 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop
- ClinicalTrials.gov ID
- NCT03835741
- Acronym / sponsor ID
- FreeO2 HypHop / 21641
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical implementation of the system used in the study as well as its routine use limited the possibilities of carrying out this project.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 11 Feb 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 this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.
Detailed description
The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.
Patients with severe acute exacerbation of COPD requiring hospitalization will be included in this randomized controlled study and will be managed with either manual oxygen titration or automated oxygen titration (FreeO2 arm).
The impact on the hospital length of stay will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated Oxygen titration | Experimental | Device: FreeO2In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device |
| Manual Oxygen titration | Other | Other: manual titrationIn this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD or suspected COPD ( Age>40, active or smoking history > 10pack/years), -
- Acute exacerbation (increasing dyspnea recently)
- One or more of the following criteria: increased sputum, modification of sputum purulence,increased dyspnea,
- Moderate oxygen therapy: Oxygen flow < 8 lpm (or FiO2 < 0.60) to maintain a SpO2 >or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 > or = 92%)
Key exclusion criteria (10 listed)
- Patient refusal
- COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose
- No SpO2 signal
- Encephalopathy score > 2
- Delirium
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 |
|---|---|---|
| FreeO2an automated adjustment of oxygen during patient hospitalisation by FreeO2 device | Device | Automated Oxygen titration |
| manual titrationa manual adjustment of oxygen during patient hospitalisation by hospital staff | Other | Manual Oxygen titration |
Primary outcome
Hospital length of stay
Time frame: From hospital admission until hospital discharge (around one week expected)
Duration of the hospital length of stay
3 secondary outcomes
ICU transfer
Time frame: During hospital stay : from hospital admission until hospital discharge (around one week expected)
Oxygen administration duration
Time frame: During hospital stay : from hospital admission until hospital discharge (around one week expected)
Non invasive or invasive mechanic ventilation rate use
Time frame: During hospital stay: from hospital admission until hospital discharge (around one week expected)
Results and safety
The study was stopped early (reason given: The clinical implementation of the system used in the study as well as its routine use limited the possibilities of carrying out this project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Oxygen Toxicity
Recruiting
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
Oxygen Toxicity, COPD Bronchitis
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Recruiting
Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
Oxygen Toxicity, Respiratory Failure
Recruiting
Oxygen Toxicity: Mechanisms in Humans
Oxygen Toxicity, Hypercapnia
Not yet recruiting
Effect of Hydrogen Gas on Hyperbaric Oxygen Toxicity
Oxygen Toxicity, Oxidative Stress
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeO2 and manual titration in people with Oxygen Toxicity and COPD Exacerbation, 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 10 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: stopped early, as of the sponsor's last update on 4 Sep 2025. 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?
The study was stopped early (reason given: The clinical implementation of the system used in the study as well as its routine use limited the possibilities of carrying out this project.). 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?
Hospital length of stay (time frame: From hospital admission until hospital discharge (around one week expected)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.