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

NCT ID: NCT05321043

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Infection Control

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Vitamin B2 labeling

Intervention Type OTHER

Using medical non-toxic fluorescent agents, VB2 solution, to mark the patient's hands before endoscopy examination.

Interventions

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Vitamin B2 labeling

Using medical non-toxic fluorescent agents, VB2 solution, to mark the patient's hands before endoscopy examination.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tsinghua University

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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SHENGYU ZHANG

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shengyu Zhang, MD

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Yuheng Zhang, MD candidate

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shengyu Zhang, M.D.

Role: CONTACT

[email protected]
+8618501155701

Facility Contacts

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Shengyu Zhang, M.D.

Role: primary

[email protected]
861018501155701

Other Identifiers

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ZS-3367

Identifier Type: -

Identifier Source: org_study_id