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

• Conditions: Hyperoxia; Hypoxia; Hypoxemia; COVID-19

• Registration Number: NCT05235386
• Lead Sponsor: Laval University

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).

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-02
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-11
• Last Update Posted: 2022-02-11
• Primary Completion: 2022-03
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval; 🇨🇦 Québec, Canada