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Risk Assessment of Indirect Exposure to the Environment in the Gastrointestinal Endoscopy Center

Primary Purpose

Infection Control

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vitamin B2 labeling
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infection Control focused on measuring infection control, indirect contagion transmission, digestive endoscopy center

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • During the study period, patients who were treated in the digestive endoscopy center of Beijing Union Medical College Hospital and planned to undergo gastroscopy. Age and gender are not limited temporarily.

Exclusion Criteria:

  • Allergic to medical non-toxic fluorescent agent: Vitamin B2 aqueous solution.
  • Poor general condition, including severe cardiopulmonary disease, difficult to tolerate examination, and coagulation disorders.
  • Patients with contraindications to endoscopy.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Vitamin B2 labeled group

Arm Description

A liquid of vitamin B2 and hand sanitizer (0.12mg/mL) is marked on the patients' hands outside the endoscopy center.

Outcomes

Primary Outcome Measures

Dosage of Indirect Contact Exposure of Environmental surfaces
A liquid of Vitamin B2 and hand sanitizer (0.12mg/mL) is marked on the hands of every patient who is scheduled in the same endoscopy work unit (usually half a day) outside the endoscopy center. Then, the doctors and nurses conduct standard EGD procedure. After this endoscopy work unit is finished, the environmental surfaces touched by the patient are sampled by the wiping method. The dosage is detected by the Fluoro Max-4® fluorophotometer (HORIBA, Japan), which is quantified as a cumulative mass (μg) over all the exposure time.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2022
Last Updated
July 10, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
Tsinghua University
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1. Study Identification

Unique Protocol Identification Number
NCT05321043
Brief Title
Risk Assessment of Indirect Exposure to the Environment in the Gastrointestinal Endoscopy Center
Official Title
Risk Assessment of Indirect Exposure to the Environment in the Gastrointestinal Endoscopy Center
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Tsinghua University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study objective: To clarify the risk of exposure to indirect contact and transmission of environmental objects during digestive endoscopy diagnosis and treatment for patients and medical staff, simulating by using Vitamin B2 solution. Study design: This is a case-only research.
Detailed Description
In the study, the object surface of the digestive endoscopy room is preliminarily analyzed, and several key exposure units, such as potential high-frequency touch areas such as the surface of the bed unit, are screened and defined. A fluorescence photographing system is arranged in the digestive endoscopy room, and the exposure unit before treatment is photographed with the best excitation wavelength of the fluorescent marker as the light source, to get the experimental background reference. Then, patients undergoing digestive endoscopy in the same endoscopy work unit (usually half a day) are selected. Before entering the digestive center, the hands of patients are fluorescently marked with vitamin B2 mixed hand sanitizer 1ml (vitamin B2 0.12mg/ml). Then, the doctors and nurses give routine care and procedure. Based on the fluorescence tracing and detection methods, the indoor light source is turned off after each selected endoscopy work unit, and the fluorescence residue on the surface of key exposed units is photographed. The environmental surfaces touched by the patient are sampled by the wiping method. The dosage is detected by the Fluoro Max-4® fluorophotometer (HORIBA, Japan), which is quantified as a cumulative mass (μg) over all the exposure time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Control
Keywords
infection control, indirect contagion transmission, digestive endoscopy center

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin B2 labeled group
Arm Type
Other
Arm Description
A liquid of vitamin B2 and hand sanitizer (0.12mg/mL) is marked on the patients' hands outside the endoscopy center.
Intervention Type
Other
Intervention Name(s)
Vitamin B2 labeling
Intervention Description
Using medical non-toxic fluorescent agents, VB2 solution, to mark the patient's hands before endoscopy examination.
Primary Outcome Measure Information:
Title
Dosage of Indirect Contact Exposure of Environmental surfaces
Description
A liquid of Vitamin B2 and hand sanitizer (0.12mg/mL) is marked on the hands of every patient who is scheduled in the same endoscopy work unit (usually half a day) outside the endoscopy center. Then, the doctors and nurses conduct standard EGD procedure. After this endoscopy work unit is finished, the environmental surfaces touched by the patient are sampled by the wiping method. The dosage is detected by the Fluoro Max-4® fluorophotometer (HORIBA, Japan), which is quantified as a cumulative mass (μg) over all the exposure time.
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: During the study period, patients who were treated in the digestive endoscopy center of Beijing Union Medical College Hospital and planned to undergo gastroscopy. Age and gender are not limited temporarily. Exclusion Criteria: Allergic to medical non-toxic fluorescent agent: Vitamin B2 aqueous solution. Poor general condition, including severe cardiopulmonary disease, difficult to tolerate examination, and coagulation disorders. Patients with contraindications to endoscopy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengyu Zhang, M.D.
Phone
+8618501155701
Email
pumchzsy@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengyu Zhang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yuheng Zhang, MD candidate
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengyu Zhang, M.D.
Phone
861018501155701
Email
pumchzsy@126.com

12. IPD Sharing Statement

Learn more about this trial

Risk Assessment of Indirect Exposure to the Environment in the Gastrointestinal Endoscopy Center

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