Respiratory DiseaseFreeO24GNCT03119727
Clinical Evaluation of FreeO2 (Version 4) in All Patients Receiving Oxygen
A study testing FreeO2 in people with Respiratory Disease and Respiratory Failure, run by Laval University at 1 site in Canada.
Trial summary
Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Disease, Respiratory Failure, COPD Exacerbation
- What is being tested?
- FreeO2
- 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
- 30 Jan 2017to 6 Nov 2020
- 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
- Age > or = 18 years old
- Patient receiving oxygen between 1 to 6 lpm for medical pathology
- Admitted to a medical service for less than 72 hours (emergency room not included)
Who cannot join
- Unreliable SpO2 signal
- Emergency or intensive care hospitalization
- Absence of NIV or intubation criteria at baseline
- Sleep apnea not paired
- Long-term Oxygen Therapy
- Active delirium and cognitive impairment preventing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Automatic Oxygen Adjustment by FreeO2 in a Medical Population in Hospital
Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)
Read the detailed description
In the previous studies, the investigators used many times automatic titration of oxygen on spontanous breathing patient (FreeO2 device) with a prototype develop in our lab in collaboration with Laval university. In this study, we want to evaluate the new version of the FreeO2 device (V4)
- Conditions
- Respiratory Disease, Respiratory Failure, COPD Exacerbation, Asthma, Pneumonia
- Being tested
- FreeO2
- Medical subject headings
- Respiration Disorders, Respiratory Insufficiency, Asthma, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeO2Device
All include patients will have automatic administration of oxygen by FreeO2 up to 3 day or until weaning of oxygen adminisatrion
| Study group | Role | What they receive |
|---|---|---|
| Automated oxygen adjustment | Other | All patient in this study have automatic oxygen titration and automatic oxygen weanning Receives: Device: FreeO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of time in the set SpO2 target
Continuous SpO2 monitoring (1 data each second) will be recorded, the % of time within the SpO2 target±2% set by the physician will be considered (Time in the target±2/Total recording time)
Measured: During 3 days of hospitalization or until Oxygen weaning
Secondary outcomes (1)
Oxygenation data
the % of time with hyperoxia (SpO2 > SpO2 target+5%), the % of time with severe hypoxemia (SpO2 <85%) the % of time without SpO2 signal, the % of time with oscillations of SpO2 values, comparison of Wired SpO2 vs Bluetooth SpO2, Daily variations of oxygen flows J1, J2 and J3
% Weaning> 50% relative baseline,% complete weaning of O2
Measured: 3 hospitalisations day or until Oxygen weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start30 Jan 2017
- Primary completion30 Apr 2019
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT03119727
- Sponsor's protocol ID
- 21342
- Acronym
- FreeO24G
- Status last verified
- Jun 2024
- First submitted
- 12 Apr 2017
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Automatic Oxygen Adjustment by FreeO2 in a Medical Population in Hospital
- ClinicalTrials.gov ID
- NCT03119727
- Acronym / sponsor ID
- FreeO24G / 21342
- Conditions
- Respiratory Disease, Respiratory Failure, COPD Exacerbation, Asthma, Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 19 Apr 2017 (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.
Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)
Detailed description
In the previous studies, the investigators used many times automatic titration of oxygen on spontanous breathing patient (FreeO2 device) with a prototype develop in our lab in collaboration with Laval university. In this study, we want to evaluate the new version of the FreeO2 device (V4)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automated oxygen adjustment | Other | Device: FreeO2All patient in this study have automatic oxygen titration and automatic oxygen weanning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > or = 18 years old
- Patient receiving oxygen between 1 to 6 lpm for medical pathology
- Admitted to a medical service for less than 72 hours (emergency room not included)
Key exclusion criteria (6 listed)
- Unreliable SpO2 signal
- Emergency or intensive care hospitalization
- Absence of NIV or intubation criteria at baseline
- Sleep apnea not paired
- Long-term Oxygen Therapy
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 |
|---|---|---|
| FreeO2All include patients will have automatic administration of oxygen by FreeO2 up to 3 day or until weaning of oxygen adminisatrion | Device | Automated oxygen adjustment |
Primary outcome
% of time in the set SpO2 target
Time frame: During 3 days of hospitalization or until Oxygen weaning
Continuous SpO2 monitoring (1 data each second) will be recorded, the % of time within the SpO2 target±2% set by the physician will be considered (Time in the target±2/Total recording time)
1 secondary outcome
Oxygenation data
Time frame: 3 hospitalisations day or until Oxygen weaning
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 20 Jun 2024.
Related trials for Respiratory Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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 in people with Respiratory Disease and Respiratory Failure, 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 3 inclusion and 6 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 20 Jun 2024. 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 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?
% of time in the set SpO2 target (time frame: During 3 days of hospitalization or until Oxygen weaning). 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 20 Jun 2024.