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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04399005
Other study ID # DACD-HuY-2005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2020
Est. completion date June 10, 2020

Study information

Verified date May 2020
Source The First Affiliated Hospital of Zhejiang Chinese Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of our study was to evaluate the difference of effectiveness between daily and after-each-case room disinfection in the endoscopy unit during the COVID-19 pandemic.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date June 10, 2020
Est. primary completion date June 5, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
after-each-case room disinfection
After-each-case room disinfection was defined as after completing each case.
daily room disinfection
Daily room disinfection was defined as disinfection after completing 8 non-general anesthesia gastroscopy or 4 general anesthesia gastroscopy.

Locations

Country Name City State
China First Affiliated Hospital of Zhejiang Chinese Medical University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Qualified rate of room disinfection 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
Primary The number of colony-forming units (CFU) 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