Daily Room DisinfectionNCT04399005
The Efficacy Comparing Daily and After-each-case Room Disinfection.
A study testing after-each-case room disinfection and daily room disinfection in people with Daily Room Disinfection and After-each-case Room Disinfection, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Daily Room Disinfection, After-each-case Room Disinfection
- What is being tested?
- after-each-case room disinfection and daily room disinfection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2020to 10 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All the cases received gastroscopy.
Who cannot join
- High-risk personal through contact history, symptoms, body temperature, COVID-19 virus nucleic acid testing and chest computed tomography (CT) scan.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
About this study
Official title: The Efficacy Comparing Daily and After-each-case Room Disinfection in the Endoscopy Unit During the COVID-19 Pandemic.
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.
Read the detailed 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).
- Being tested
- after-each-case room disinfection, daily room disinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
after-each-case room disinfectionOther
After-each-case room disinfection was defined as after completing each case.
daily room disinfectionOther
Daily room disinfection was defined as disinfection after completing 8 non-general anesthesia gastroscopy or 4 general anesthesia gastroscopy.
| Study group | Role | What they receive |
|---|---|---|
| daily room disinfection | Experimental | 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. Receives: Other: daily room disinfection |
| after-each-case room disinfection | Experimental | 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. Receives: Other: after-each-case room disinfection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start25 May 2020
- Primary completion5 Jun 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Daily Room DisinfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Lu, Principal investigator, First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399005
- Sponsor's protocol ID
- DACD-HuY-2005
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data sharing will be consider after study
Publications
Jin B, Hu Y, Huang L, Cheng X, Zhao J, Yang X, Sun X, Gan T, Lu B. Effectiveness Between Daily and After-Each-Case Room Disinfection of the Endoscopy Unit. Front Public Health. 2021 Oct 5;9:700041. doi: 10.3389/fpubh.2021.700041. eCollection 2021.
PubMed 34676191
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Comparing Daily and After-each-case Room Disinfection in the Endoscopy Unit During the COVID-19 Pandemic.
- ClinicalTrials.gov ID
- NCT04399005
- Acronym / sponsor ID
- DACD-HuY-2005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| daily room disinfection | Experimental | Other: daily room disinfectionRoom 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. |
| after-each-case room disinfection | Experimental | Other: after-each-case room disinfectionRoom 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All the cases received gastroscopy.
Key exclusion criteria (1 listed)
- High-risk personal through contact history, symptoms, body temperature, COVID-19 virus nucleic acid testing and chest computed tomography (CT) scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| after-each-case room disinfectionAfter-each-case room disinfection was defined as after completing each case. | Other | after-each-case room disinfection |
| daily room disinfectionDaily room disinfection was defined as disinfection after completing 8 non-general anesthesia gastroscopy or 4 general anesthesia gastroscopy. | Other | daily room disinfection |
Primary outcome
Qualified rate of room disinfection
Time frame: 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.
The number of colony-forming units (CFU)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Derived from this study: PubMed 34676191Jin B, Hu Y, Huang L, Cheng X, Zhao J, Yang X, Sun X, Gan T, Lu B. Effectiveness Between Daily and After-Each-Case Room Disinfection of the Endoscopy Unit. Front Public Health. 2021 Oct 5;9:700041. doi: 10.3389/fpubh.2021.700041. eCollection 2021.
- Individual participant dataSharing planned: Undecided. individual participant data sharing will be consider after study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Lu principal investigator
First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing after-each-case room disinfection and daily room disinfection in people with Daily Room Disinfection and After-each-case Room Disinfection, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualified rate of room disinfection (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.