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

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.

Study Overview

• Status: Recruiting
• Conditions: Infection Control
• Intervention / Treatment: Other: Vitamin B2 labeling

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). Meanwhile, the process of the gastroscopy is recorded by camera for the recognition of touch behaviors. 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. Then the video of the gastroscopy process is analyzed for the recognition of touch behaviors. 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shengyu Zhang, M.D.; Phone Number: +8618501155701; Email: pumchzsy@126.com

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Shengyu Zhang, M.D.; Phone Number: 861018501155701; Email: pumchzsy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vitamin B2 labeled group; A liquid of vitamin B2 and hand sanitizer (0.12mg/mL) is marked on the patients' hands outside the endoscopy center.	Other: Vitamin B2 labeling; Using medical non-toxic fluorescent agents, VB2 solution, to mark the patient's hands before endoscopy examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Tsinghua University
• Investigators: Study Director: Shengyu Zhang, MD, Peking Union Medical College Hospital; Principal Investigator: Yuheng Zhang, MD candidate, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: infection control; indirect contagion transmission; digestive endoscopy center
• Additional Relevant MeSH Terms: Infections; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin
• Other Study ID Numbers: ZS-3367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No