COVID-19NCT05235386
Clinical Impact of Automated Oxygen Administration on Confirmed or Suspected COVID-19 in the Emergency Department.
An observational study of COVID-19 and Hypoxemia, run by Laval University at 1 site in Canada.
Trial summary
The aim of this study is to evaluate the impact of the FreeO2 system on the quality of the oxygen therapy in confirmed or suspected SARS-CoV-2 patients in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Automated oxygen titration
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2022to Dec 2022
- Phase
- Observational
- 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
Study population: Confirmed or suspected SARS-CoV-2 patient aged 18 years old or older on automated oxygen therapy in the emergency department.
Who may be able to join
- Hypoxemic patients on automated oxygen therapy during their emergency department stay
- Confirmed or suspected SARS-CoV-2 patients in the emergency department
Who cannot join
- Patient on automated oxygen therapy in the emergency department without accessible data of the FreeO2 device.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval
Québec, G1V 4G5
François Lellouche, MD,PhD, 418-656-8711 ext. 3572, francois.lellouche@criucpq.ulaval.ca
François Lellouche, Md,PhD
About this study
The aim of this study is to evaluate the impact of the FreeO2 system on the quality of the oxygen therapy in confirmed or suspected SARS-CoV-2 patients in the emergency department.
Read the detailed description
The aim of this study is to evaluate the impact of the FreeO2 system on the quality of the oxygen therapy in confirmed or suspected SARS-CoV-2 patients in the emergency department. The quality of oxygen therapy is evaluated by the time spent in the SpO2 target (+/- 2% SpO2 target), time spent in hyperoxemia (> 5% SpO2 target), time spent in hyperoxemia (<5% SpO2 target).
- Being tested
- Automated oxygen titration
- Keywords
- Oxygen therapy, Automated titration
- Medical subject headings
- COVID-19, Hypoxia, Hyperoxia
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 administration to maintain the SpO2 target at a predefined value during emergency length of stay
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in the saturation target in patients on automated oxygen titration device.
The percentage of time in target is defined by the percentage of time of (Target - 3% target) < SpO2 value < (Target + 3%) of the selected Spo2 target using automated oxygen titration device.
Measured: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Secondary outcomes (8)
Oxygenation data - hyperoxemia
The percentage of time in hyperoxemia defined as a SpO2 value > 5% from the target.
Measured: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Oxygenation data - severe hypoxemia
The percentage of time in hypoxemia defined as a SpO2 value < 85%
Measured: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Oxygenation data - mild hypoxemia
The percentage of time in mild hypoxemia defined as a : (Target - 5% target) < SpO2 value < (Target - 2%)
Measured: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
automated oxygen therapy duration
Length of total time on automated oxygen therapy in the emergency department in hours.
Measured: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Ventilatory support
Need of change in ventilatory support device : (mechanical ventilation, non-invasive mechanical ventilation, high flow nasal canula, oxygen therapy) during emergency length of stay
Measured: From the initiation of oxygen therapy with FreeO2 until hospital discharge, assessed up to 2 months after emergency admission
Emergency length of stay.
Time of stay in hours in the emergency department.
Measured: From emergency departement admission until the date of emergency department discharge assessed up to 3 day after emergency admission
Hospital length of stay.
Time of stay in hours during hospitalisation Time of stay in hospitalisation setting (excluding the intensive care unit) and intensive care unit in days.
Measured: From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission
Orientation of care
Describe departement admission (emergency observation, general ward ,intensive care unit)
Measured: From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
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
- NCT05235386
- Sponsor's protocol ID
- FreeO2 COVID-19 urgence
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2022
- Last updated
- 11 Feb 2022
- 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 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Automated Oxygen Administration on Confirmed or Suspected COVID-19 in the Emergency Department.
- ClinicalTrials.gov ID
- NCT05235386
- Acronym / sponsor ID
- FreeO2 COVID-19 urgence
- Keywords
- Oxygen therapy, Automated titration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Feb 2022 (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 the impact of the FreeO2 system on the quality of the oxygen therapy in confirmed or suspected SARS-CoV-2 patients in the emergency department.
Detailed description
The aim of this study is to evaluate the impact of the FreeO2 system on the quality of the oxygen therapy in confirmed or suspected SARS-CoV-2 patients in the emergency department. The quality of oxygen therapy is evaluated by the time spent in the SpO2 target (+/- 2% SpO2 target), time spent in hyperoxemia (> 5% SpO2 target), time spent in hyperoxemia (<5% SpO2 target).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed or suspected SARS-CoV-2 patient aged 18 years old or older on automated oxygen therapy in the emergency department.
Key inclusion criteria (2 listed)
- Hypoxemic patients on automated oxygen therapy during their emergency department stay
- Confirmed or suspected SARS-CoV-2 patients in the emergency department
Key exclusion criteria (1 listed)
- Patient on automated oxygen therapy in the emergency department without accessible data of the FreeO2 device.
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.inc.Automated oxygen administration to maintain the SpO2 target at a predefined value during emergency length of stay | Device | – |
Primary outcome
Percentage of time in the saturation target in patients on automated oxygen titration device.
Time frame: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
The percentage of time in target is defined by the percentage of time of (Target - 3% target) < SpO2 value < (Target + 3%) of the selected Spo2 target using automated oxygen titration device.
8 secondary outcomes
Oxygenation data - hyperoxemia
Time frame: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Oxygenation data - severe hypoxemia
Time frame: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Oxygenation data - mild hypoxemia
Time frame: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
automated oxygen therapy duration
Time frame: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Ventilatory support
Time frame: From the initiation of oxygen therapy with FreeO2 until hospital discharge, assessed up to 2 months after emergency admission
Emergency length of stay.
Time frame: From emergency departement admission until the date of emergency department discharge assessed up to 3 day after emergency admission
Hospital length of stay.
Time frame: From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission
Orientation of care
Time frame: From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Hypoxemia, 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 2 inclusion and 1 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 11 Feb 2022. 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 François Lellouche, MD, PhD (418-656-8711 ext. 3572, francois.lellouche@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time in the saturation target in patients on automated oxygen titration device. (time frame: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission). 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 11 Feb 2022.