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Clinical Impact of Automated Oxygen Administration on Confirmed or Suspected COVID-19 in the Emergency Department.

Clinical Impact of Automated Oxygen Administration on Confirmed or Suspected COVID-19 in the Emergency Department.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05235386
Enrollment
60
Registered
2022-02-11
Start date
2022-02-28
Completion date
2022-12-31
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Hypoxemia, Hyperoxia, Hypoxia

Keywords

Oxygen therapy, Automated titration

Brief 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.

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).

Interventions

Automated oxygen administration to maintain the SpO2 target at a predefined value during emergency length of stay

Sponsors

Laval University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hypoxemic patients on automated oxygen therapy during their emergency department stay * Confirmed or suspected SARS-CoV-2 patients in the emergency department

Exclusion criteria

* Patient on automated oxygen therapy in the emergency department without accessible data of the FreeO2 device.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of time in the saturation target in patients on automated oxygen titration device.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 admissionThe 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.

Secondary

MeasureTime frameDescription
Oxygenation data - severe hypoxemiaFrom 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 admissionThe percentage of time in hypoxemia defined as a SpO2 value \< 85%
Oxygenation data - mild hypoxemiaFrom 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 admissionThe percentage of time in mild hypoxemia defined as a : (Target - 5% target) \< SpO2 value \< (Target - 2%)
automated oxygen therapy durationFrom 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 admissionLength of total time on automated oxygen therapy in the emergency department in hours.
Oxygenation data - hyperoxemiaFrom 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 admissionThe percentage of time in hyperoxemia defined as a SpO2 value \> 5% from the target.
Emergency length of stay.From emergency departement admission until the date of emergency department discharge assessed up to 3 day after emergency admissionTime of stay in hours in the emergency department.
Hospital length of stay.From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admissionTime of stay in hours during hospitalisation Time of stay in hospitalisation setting (excluding the intensive care unit) and intensive care unit in days.
Orientation of careFrom emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admissionDescribe departement admission (emergency observation, general ward ,intensive care unit)
Ventilatory supportFrom the initiation of oxygen therapy with FreeO2 until hospital discharge, assessed up to 2 months after emergency admissionNeed of change in ventilatory support device : (mechanical ventilation, non-invasive mechanical ventilation, high flow nasal canula, oxygen therapy) during emergency length of stay

Countries

Canada

Contacts

Primary ContactFrançois Lellouche, MD, PhD
francois.lellouche@criucpq.ulaval.ca418-656-8711
Backup ContactLéa Dallaire, MD
lea.dallaire.1@ulaval.ca438-868-8022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026