Clinical trial NCT05235386: Clinical Impact of Automated Oxygen Administration on Confirmed or Suspected COVID-19 in the Emergency Department.
Official title: Clinical Impact of Automated Oxygen Administration on Confirmed or Suspected COVID-19 in the Emergency Department.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Hypoxemia
Hyperoxia
Hypoxia
Keywords: Oxygen therapy
Automated titration
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Confirmed or suspected SARS-CoV-2 patient aged 18 years old or older on automated oxygen therapy in the emergency department.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of time in the saturation target in patients on automated oxygen titration device.
timeFrame: 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:
measure: Oxygenation data - hyperoxemia
timeFrame: 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
measure: Oxygenation data - severe hypoxemia
timeFrame: 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
measure: Oxygenation data - mild hypoxemia
timeFrame: 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
measure: automated oxygen therapy duration
timeFrame: 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
measure: Ventilatory support
timeFrame: From the initiation of oxygen therapy with FreeO2 until hospital discharge, assessed up to 2 months after emergency admission
measure: Emergency length of stay.
timeFrame: From emergency departement admission until the date of emergency department discharge assessed up to 3 day after emergency admission
measure: Hospital length of stay.
timeFrame: From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission
measure: Orientation of care
timeFrame: From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval
Study officials:
References: