- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01485237
Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization
1. december 2015 opdateret af: Dr. Anand Kumar, University of Manitoba
The main purpose of this study is to review the resource utilization of severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg.
Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS).
The investigators will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards.
The investigators will determine the resources used by both groups and compare.
Finally the investigators will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
400
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3A 1R9
- Health Sciences Centre, Winnipeg
-
-
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
Patients with severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg.
Patients with other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS)that may require some of the same treatments.
Beskrivelse
Inclusion Criteria:
- > 18years,
- Suspected or confirmed influenza (Appendix A)
- Requirement for ICU admission due to respiratory distress or critical illness defined as one of:a) Inspired oxygen need of >50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B) b) mechanical ventilation c) Patient is receiving inotrope or vasopressor
Exclusion Criteria:
1. Age less than 18 years
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Severe H1N1 pneumonia in adult patients
Severe adult H1N1 pneumonia patients undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO)in Winnipeg
|
The main purpose of this study is to review the resource utilization.
Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS).
We will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards.
We will determine the resources used by both groups and compare.
Finally we will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.
|
|
Severe pneumonia in adults not H1N1
Patients admitted to the hospital and/or ICU with viral pneumonia, bacterial pneumonia, septic shock, ARDS in Winnipeg
|
The main purpose of this study is to review the resource utilization.
Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS).
We will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards.
We will determine the resources used by both groups and compare.
Finally we will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Anand Kumar, MD, Health Sciences Centre, Winnipeg
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
1. oktober 2009
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. december 2012
Datoer for studieregistrering
Først indsendt
1. december 2011
Først indsendt, der opfyldte QC-kriterier
2. december 2011
Først opslået (Skøn)
5. december 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. december 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- pandemic001
- H2009:175 (Anden identifikator: University of Manitoba Research Ethics Board Identifier:)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .