Aerosol Particle From EGD in Patients With and Without Head Box in COVID-19 Era

Study Overview
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Brief Summary
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According to preexisting data, it has revealed the fundamental role that aerosols play in the transmission of the COVID-19 virus. Esophagogastroduodenoscopy (EGD), producing particle smaller than 5 microns, was regarded as 'aerosol-generating procedures' (AGPs) associated with an increased risk of transmission of respiratory pathogens to healthcare workers. The strategies aim to reduce spreading of aerosol during the procedure should be beneficial. Using an acrylic box to cover the head of a patient undergoing an endoscopy seems to reduce aerosol scatter and reduce the spread of respiratory pathogens. At present, there are no high-quality studies that provide quantitative data on the use of head box to reduce aerosol generation.

Detailed Description
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Pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affected globally clinical practice including temporary postponement of elective endoscopic procedures in GI office activity and has caused an unprecedent concern in personal protection against the airborne virus. Whitin 2.5 years since the outbreak in mid-December 2019, COVID-19 had infected over 182 million people and killed more than 3.9 million across 210 countries worldwide. (Ref. https://www.who.int/emergencies/diseases/novel-coronavirus-2019). According to preexisting data, it has revealed the fundamental role that aerosols play in the transmission of the COVID-19 virus. Previously, in the medical community attempted to find strategies to minimize risk of respiratory transmission to HCPs during pandemic such as wearing either standard or full personal protective equipment (PPE), including do-it-yourself devices and gadgets are the necessary substitutes to protect them from aerosolization. However, there has been no published study evaluating the efficacy or real benefit of these tools in preventing aerosolization during EGD quantitatively. Esophagogastroduodenoscopy (EGD), producing particle smaller than 5 microns, was regarded as 'aerosol-generating procedures' (AGPs) associated with an increased risk of transmission of respiratory pathogens to healthcare workers. The strategies aim to reduce spreading of aerosol during the procedure should be beneficial. Using an acrylic box to cover the head of a patient undergoing an endoscopy seems to reduce aerosol scatter and reduce the spread of respiratory pathogens. At present, there are no high-quality studies that provide quantitative data on the use of head box to reduce aerosol generation.

Official Title
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The Comparison of Level of Aerosol Particle at the Face Level of Endoscopist Performing Upper Gastrointestinal Endoscopy in Patients With and Without Head Box; a Randomized Control Trial

Conditions
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EGD, Covid19, Aerosol Disease, Head Box

Intervention / Treatment
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* Device: Head box during upper gastrointestinal endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who indicated in upper gastrointestinal endoscopy and undergoing endoscopy at Excellence Center For GI Endoscopy, King Chulalongkorn Memorial Hospital, Thailand Age of 18 years or more Exclusion Criteria: Patients with a high risk of conscious sedation who need an anesthetist Patients with refusal to participate in clinical research Patients who cannot make medical decisions on their own Patients who underwent therapeutic endoscopy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing upper gastrointestinal endoscopy with head box<br>experimental group | Device: Head box during upper gastrointestinal endoscopy<br>* ็Head box is an acrylic box over a patient's head who undergoing upper gastrointestinal endoscopy.<br>|
| No Intervention: Patients undergoing upper gastrointestinal endoscopy without head box<br>standard of care group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of aerosol particles measured on the face of th endoscopist performing an upper gastrointestinal endoscopy | Aerosol particles measured by portable particle counter as count per cubic foot | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper gastrointestinal endoscopy, EGD, COVID-19, Aerosol-generating procedure, Head box