- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04399005
The Efficacy Comparing Daily and After-each-case Room Disinfection.
The Efficacy Comparing Daily and After-each-case Room Disinfection in the Endoscopy Unit During the COVID-19 Pandemic.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
This study divided into 2 groups: daily room disinfection and after-each-case room disinfection. Each group was also subdivided into general anesthesia or non-general anesthesia gastroscopy, and with or without ventilation consultation room.
Samples collection include: operation unit air (six-stage sieve percussion air sampler for sampling, airflow rate 28.3L/min, sampling time 4 min); workstation's mouse (wiping sterile cotton for sampling); endoscopist's gown, control panel buttons, and patient's bed headboard (contact plate for sampling).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina, 310006
- First Affiliated Hospital of Zhejiang Chinese Medical University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- All the cases received gastroscopy.
Exclusion Criteria:
- High-risk personal through contact history, symptoms, body temperature, COVID-19 virus nucleic acid testing and chest computed tomography (CT) scan.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: daily room disinfection
Room disinfection was defined as the cleansing and disinfection of the surface of the facility, endoscopist's gown, and air in the endoscopy room after the examination.
Specifically, sanitizing wipes wiped the surface of the facility one by one, containing quaternary ammonium salt, alcohol, and interfacial activator; the air disinfection machine continued for 30min of air disinfection.
Daily room disinfection was defined as disinfection after completing 8 non-general anesthesia gastroscopy or 4 general anesthesia gastroscopy.
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Daily room disinfection was defined as disinfection after completing 8 non-general anesthesia gastroscopy or 4 general anesthesia gastroscopy.
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Eksperimentel: after-each-case room disinfection
Room disinfection was defined as the cleansing and disinfection of the surface of the facility, endoscopist's gown, and air in the endoscopy room after the examination.
Specifically, sanitizing wipes wiped the surface of the facility one by one, containing quaternary ammonium salt, alcohol, and interfacial activator; the air disinfection machine continued for 30min of air disinfection.
After-each-case room disinfection was defined as after completing each case.
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After-each-case room disinfection was defined as after completing each case.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Qualified rate of room disinfection
Tidsramme: 48 hours
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The samples of workstation's mouse, control panel buttons and patient's bed headboard greater than 10 CFU/cm2, samples of endoscopist's gown greater than 200 CFU/suit, and samples of operation unit air greater than 500 CFU/m3 are deemed as an unacceptable level of bioburden.
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48 hours
|
|
The number of colony-forming units (CFU)
Tidsramme: 48 hours
|
The number of colony-forming units (CFU) of operation unit air, workstation's mouse, endoscopist's gown, control panel buttons, and patient's bed headboard.
|
48 hours
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Bin Lu, First Affiliated Hospital of Zhejiang Chinese Medical University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- DACD-HuY-2005
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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