Clinical trial NCT04400734: Esophagogastroduodenoscopy (EGD) is an Aerosol-generating Procedure: Proof of Concept Study
Official title: Esophagogastroduodenoscopy (EGD) is an Aerosol-generating Procedure: Proof of Concept Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aerosol-generating Procedure, Esophagogastroduodenoscopy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed description: 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. Currently, the term droplet is often taken to refer to droplets \>5 microns (μm) in diameter that fall rapidly to the ground under gravity, and therefore are transmitted only over a limited distance (e.g. ≤1 m). In contrast, the term droplet nuclei refers to droplets ≤5 μm in diameter that can remain suspended in air for significant periods of time, allowing them to be transmitted over distances \>1 metre. 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. With the use of a commercial available particle counter, the number of particles of size (0.3um, 0.5um, 0.7um, 1um, 5um and 1um) are recorded. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The increase in particle counts of particle size (0.3um, 0.5um, 0.7um, 1um, 5um, 10um) during the procedure
timeFrame: during the procedure
Secondary outcomes:
measure: Procedure time
timeFrame: during the procedure
measure: Use of sedation
timeFrame: during the procedure
measure: Use of continuous suction
timeFrame: during the procedure
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of hong Kong
Study officials:
References: