Exposure Measurements and Interventions for Aerosol Produced by Gastrointestinal Endoscopy

Study objective: To clarify the risk of exposure to the exhaled aerosol droplets from patients for medical staffs during digestive endoscopy via labelling the oral mucosa with vitamin B2 solution, and evaluate the protective efficacy of personal protective equipment.

Study design: This is a prospective randomized controlled study.

Study Overview

• Status: Completed
• Conditions: Droplet Transmission
• Intervention / Treatment: Device: masks (surgical mask, respirator)

Detailed Description

This is a prospective randomized controlled study. Patients who meet the inclusion criteria and do not meet the exclusion criteria are recruited for this trial. They will be randomly divided into the control group and the intervention group (A total of 70 subjects, and 35 per group based on calculation of sample size). The in vitro bionic model next to the doctor simulated a medical staff, which is printed via the stereolithographic appearance 3D printing technique following the morphological structure data of human face and airway obtained by processing CT images, will either wear a mask or not, depending on the intervention group (in the intervention group, in vitro model wears personal protective equipment). Before starting the esophagogastroduodenoscopy (EGD) under anesthesia, vitamin B2 saline solution (vitamin B2 dosage determined by the suggested daily nutrient uptake in China) is dripped in their mouths. When the examination is finished, the dosage of facial mucosa deposition and airway inhalation of the in vitro model is quantified as a cumulative droplet mass (μg) over all the exposure time. The deposited droplets are collected by wiping method, and the inhaled droplets are sampled by a solution-based sampler (SKC, U.S.A.). The dosage is detected by the Fluoro Max-4® fluorophotometer (HORIBA, Japan). By comparing and analyzing the results of the two intervention groups, the researchers try to evaluate the risk of exposure under the personal protective equipment and assess the effectiveness of it.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who have ever been allergic to the medical non-toxic fluorescent agent ( vitamin B2 saline solution).
• Patients who received anti-tumor therapy during the period of digestive endoscopy.
• Patients with poor general conditions, including severe cardiopulmonary diseases, coagulation disorders, or a total of platelet less than 50*10^9/L.
• Patients with structural pulmonary disease (chronic obstructive pulmonary disease, asthma, etc.) or airway/pulmonary surgery history
• Patients with intolerance or contraindications to digestive endoscopy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group: Mask on model face; The mask (surgical mask, respirator) will be worn on the face of the in vitro bionic model. Vitamin B2 saline solution of the same dose will be dripped into each patient's mouth before EGD examination, as a fluorescent tracer.	Device: masks (surgical mask, respirator); The mask (surgical mask, respirator) will be worn on the face of the in vitro bionic model in the procedure room for measuring droplet exposure.
No Intervention: Control group: No mask on model face; No mask (surgical mask, respirator) will be worn on the face of the in vitro bionic model. Vitamin B2 saline solution of the same dose will be dripped into each patient's mouth before EGD examination, as a fluorescent tracer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of in vitro model airway inhalation of patient's exhaled droplets	After EGD examination, the dosage of airway inhalation of the in vitro model is quantified as a cumulative droplet mass (μg) over all the exposure time. The deposited droplets are collected by wiping method, and the inhaled droplets are sampled by a solution-based sampler (SKC, U.S.A.). The dosage is detected by the Fluoro Max-4® fluorophotometer (HORIBA, Japan).	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of in vitro model facial mucosa deposition of patient's exhaled droplets	After EGD examination, the dosage of facial mucosa deposition of the in vitro model is quantified as a cumulative droplet mass (μg) over all the exposure time. The deposited droplets are collected by wiping method, and the inhaled droplets are sampled by a solution-based sampler (SKC, U.S.A.). The dosage is detected by the Fluoro Max-4® fluorophotometer (HORIBA, Japan).	one year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Tsinghua University
• Investigators: Study Director: Shengyu Zhang, M.D., Peking Union Medical College Hospital; Principal Investigator: Zhiyu Yan, M.D. Program, Peking Union Medical College Hospital; Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 1, 2024

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Personal protective equipment; Exposure Risk; Digestive Endoscopy
• Other Study ID Numbers: ZS-3377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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