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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05235386
• Other study ID #: FreeO2 COVID-19 urgence
• Status: Not yet recruiting
• Start date: February 2022
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Laval University
• Contact: François Lellouche, MD, PhD
• Phone: 418-656-8711
• Email: francois.lellouche[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Emergencies
• Hyperoxia
• Hypoxemia
• Hypoxia

Intervention

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

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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