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

Infection Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321043
• Other study ID #: ZS-3367
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: Peking Union Medical College Hospital
• Contact: Shengyu Zhang, M.D.
• Phone: +8618501155701
• Email: pumchzsy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection Control
• Infections

Intervention

Other:
• Vitamin B2 labeling
Using medical non-toxic fluorescent agents, VB2 solution, to mark the patient's hands before endoscopy examination.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Tsinghua University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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