Esophagogastroduodenoscopy (EGD) is an Aerosol-generating Procedure: Proof of Concept Study

NCT04400734 | Unknown

• 1 other identifier: 2020.200
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The disease COVID-19 has been classified as pandemic by World Health Organisation (WHO) in March 2020. This poses a risk to healthcare workers. Whether esophagogastroduodenoscopy (EGD) is a aerosol-generating procedure (AGP) has brought controversy. Multiple international guidelines consider EGD as AGP based on expert consensus. No scientific data has been published regarding this. With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of \< 5um during or after the procedure would suggest that the procedure is an AGP. The baseline particle counts before and during the procedure are also recorded. The details of the procedure including procedure time and the use of sedation are also documented.

Conditions

Aerosol-generating Procedure, Esophagogastroduodenoscopy

Outcome Measures

Primary Outcomes (1)

• The increase in particle counts of particle size (0.3um, 0.5um, 0.7um, 1um, 5um, 10um) during the procedure

  during the procedure

Secondary Outcomes (3)

• Procedure time

  during the procedure

• Use of sedation

  during the procedure

• Use of continuous suction

  during the procedure

Interventions

No intervention, observational study OTHER

no intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing EGD in the endoscopy unit of Prince of wales Hospital, Shatin, Hong Kong will be included

You may qualify if:

• All patients undergoing EGD in the endoscopy unit of Prince of wales Hospital, Shatin, Hong Kong

You may not qualify if:

• EGD cannot be completed due to patient's condition
• Patients who are unstable and require extra medical attention
• Patients who refuse
• Patients who are not fit for consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Shannon Chan, FRCSEd

CONTACT

852-35052627; shannonchan@surgery.cuhk.edu.hk

Philip Chiu, FRCSEd

CONTACT

852-35052627; philipchiu@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: May 7, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)