Automated oxygen titration i Covid-19 og Hypoksi og Hypoksemi - Klinisk prøveregister

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Enhet: Automated oxygen titration

Detaljert 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).

Studietype

Observasjonsmessig

Registrering (Forventet)

60

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: François Lellouche, MD, PhD
Telefonnummer: 3572 418-656-8711
E-post: Francois.Lellouche@criucpq.ulaval.ca

Studer Kontakt Backup

Navn: Léa Dallaire, MD
Telefonnummer: 438-868-8022
E-post: lea.dallaire.1@ulaval.ca

Studiesteder

Canada
- - Québec, Canada, G1V 4G5
    - Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
    - Ta kontakt med:
      
      François Lellouche, MD,PhD
      
      Telefonnummer: 3572 418-656-8711
      
      E-post: francois.lellouche@criucpq.ulaval.ca
    - Hovedetterforsker:
      
      François Lellouche, Md,PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Laval University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. februar 2022

Primær fullføring (Forventet)

1. mars 2022

Studiet fullført (Forventet)

1. desember 2022

Datoer for studieregistrering

Først innsendt

3. februar 2022

Først innsendt som oppfylte QC-kriteriene

9. februar 2022

Først lagt ut (Faktiske)

11. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)