- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310006
- First Affiliated Hospital of Zhejiang Chinese Medical University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Daily room disinfection was defined as disinfection after completing 8 non-general anesthesia gastroscopy or 4 general anesthesia gastroscopy.
|
|
Eksperimentell: 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.
|
After-each-case room disinfection was defined as after completing each case.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Qualified rate of room disinfection
Tidsramme: 48 hours
|
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.
|
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Bin Lu, First Affiliated Hospital of Zhejiang Chinese Medical University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- DACD-HuY-2005
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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