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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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COVID-19, Hypoxemia, Hyperoxia, Hypoxia

Intervention / Treatment
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* Device: Automated oxygen titration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Automated oxygen titration|Automated oxygen administration to maintain the SpO2 target at a predefined value during emergency length of stay|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation data - hyperoxemia | The percentage of time in hyperoxemia defined as a SpO2 value > 5% from the target. | 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% | 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%) | 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. | 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 | 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. | 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. | 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) | From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen therapy, Automated titration