Exposure Measurements and Interventions for Aerosol Produced by Gastrointestinal Endoscopy

NCT ID: NCT05321056

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-17
• Study Completion Date: 2024-12-01

Brief Summary

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.

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.

Conditions

Droplet Transmission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

masks (surgical mask, respirator)

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tsinghua University

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

SHENGYU ZHANG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shengyu Zhang, M.D.

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Zhiyu Yan, M.D. Program

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital; Peking Union Medical College

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

References

Zhang S, Yan Z, Zhang Y, Wu X, Liu L, Yang A, Duan M. Protocol of a randomised controlled trial to assess medical staff's inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context. BMJ Open. 2023 Feb 28;13(2):e068291. doi: 10.1136/bmjopen-2022-068291.

Reference Type: DERIVED

PMID: 36854596 (View on PubMed)

Other Identifiers

ZS-3377

Identifier Type: -

Identifier Source: org_study_id