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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05321043
Enrollment
100
Registered
2022-04-11
Start date
2022-07-01
Completion date
2025-06-01
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Control

Keywords

infection control, indirect contagion transmission, digestive endoscopy center

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). 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.

Interventions

OTHERVitamin B2 labeling

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

Sponsors

Tsinghua University
CollaboratorOTHER
Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dosage of Indirect Contact Exposure of Environmental surfacesone yearA 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.

Countries

China

Contacts

Primary ContactShengyu Zhang, M.D.
pumchzsy@126.com+8618501155701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026