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

NCT05235386 | Unknown

• 1 other identifier: FreeO2 COVID-19 urgence
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Hypoxemia; Hyperoxia; Hypoxia

Keywords

Oxygen therapy; Automated titration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• 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

• Ventilatory support

  From the initiation of oxygen therapy with FreeO2 until hospital discharge, assessed up to 2 months after emergency admission

Interventions

Automated oxygen titration DEVICE

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

Also known as: FreeO2 System TM, Oxy'nov.inc.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Hypoxemic patients on automated oxygen therapy during their emergency department stay
• Confirmed or suspected SARS-CoV-2 patients in the emergency department

You may not qualify if:

• Patient on automated oxygen therapy in the emergency department without accessible data of the FreeO2 device.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval

Québec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

COVID-19; Hypoxia; Hyperoxia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

François Lellouche, MD, PhD

CONTACT

418-656-8711; francois.lellouche@criucpq.ulaval.ca

Léa Dallaire, MD

CONTACT

438-868-8022; lea.dallaire.1@ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 11, 2022
• Study Start: February 1, 2022
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)