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Clinical Trials/NCT05235386
NCT05235386
Unknown
Not Applicable

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

Laval University1 site in 1 country60 target enrollmentFebruary 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Laval University
Enrollment
60
Locations
1
Primary Endpoint
Percentage of time in the saturation target in patients on automated oxygen titration device.
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 2022
End Date
December 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

François Lellouche

Principal Investigator

Laval University

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.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Emergency length of stay.(From emergency departement admission until the date of emergency department discharge assessed up to 3 day after emergency admission)
  • Hospital length of stay.(From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission)
  • 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)
  • 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)
  • 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)
  • Orientation of care(From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission)
  • 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)
  • Ventilatory support(From the initiation of oxygen therapy with FreeO2 until hospital discharge, assessed up to 2 months after emergency admission)

Study Sites (1)

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