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

9. februar 2022 opdateret af: François Lellouche, Laval University
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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Forventet)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
      • Québec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval
        • Kontakt:
        • Ledende efterforsker:
          • François Lellouche, Md,PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Confirmed or suspected SARS-CoV-2 patient aged 18 years old or older on automated oxygen therapy in the emergency department.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of time in the saturation target in patients on automated oxygen titration device.
Tidsramme: 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.
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oxygenation data - hyperoxemia
Tidsramme: 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.
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
Tidsramme: 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%
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
Tidsramme: 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%)
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
Tidsramme: 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.
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
Tidsramme: 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
From the initiation of oxygen therapy with FreeO2 until hospital discharge, assessed up to 2 months after emergency admission
Emergency length of stay.
Tidsramme: 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.
From emergency departement admission until the date of emergency department discharge assessed up to 3 day after emergency admission
Hospital length of stay.
Tidsramme: 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.
From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission
Orientation of care
Tidsramme: 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)
From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Laval University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. februar 2022

Primær færdiggørelse (Forventet)

1. marts 2022

Studieafslutning (Forventet)

1. december 2022

Datoer for studieregistrering

Først indsendt

3. februar 2022

Først indsendt, der opfyldte QC-kriterier

9. februar 2022

Først opslået (Faktiske)

11. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FreeO2 COVID-19 urgence

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med COVID-19

Kliniske forsøg med Automated oxygen titration

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Betingelser

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Placeringer

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