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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981535
• Other study ID #: RP022
• Status: Completed
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: King Chulalongkorn Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 30, 2022
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aerosol Disease
• COVID-19
• Covid19

Intervention

Device:
• Head box during upper gastrointestinal endoscopy
"?Head box" is an acrylic box over a patient's head who undergoing upper gastrointestinal endoscopy.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (8)

Chan SM, Ma TW, Chong MK, Chan DL, Ng EKW, Chiu PWY. A Proof of Concept Study: Esophagogastroduodenoscopy Is an Aerosol-Generating Procedure and Continuous Oral Suction During the Procedure Reduces the Amount of Aerosol Generated. Gastroenterology. 2020 N — View Citation

Gregson FKA, Shrimpton AJ, Hamilton F, Cook TM, Reid JP, Pickering AE, Pournaras DJ, Bzdek BR, Brown J; AERATOR group. Identification of the source events for aerosol generation during oesophago-gastro-duodenoscopy. Gut. 2022 May;71(5):871-878. doi: 10.11 — View Citation

Hennessy B, Vicari J, Bernstein B, Chapman F, Khaykis I, Littenberg G, Robbins D. Guidance for resuming GI endoscopy and practice operations after the COVID-19 pandemic. Gastrointest Endosc. 2020 Sep;92(3):743-747.e1. doi: 10.1016/j.gie.2020.05.006. Epub — View Citation

Meselson M. Droplets and Aerosols in the Transmission of SARS-CoV-2. N Engl J Med. 2020 May 21;382(21):2063. doi: 10.1056/NEJMc2009324. Epub 2020 Apr 15. — View Citation

Pittayanon R, Faknak N, Ananchuensook P, Prasoppokakorn T, Plai-Dum S, Thummongkhol T, Paitoonpong L, Rerknimitr R. Amount of contamination on the face shield of endoscopists during upper endoscopy between patients in two positions: A randomized study. J — View Citation

Sagami R, Nishikiori H, Sato T, Tsuji H, Ono M, Togo K, Fukuda K, Okamoto K, Ogawa R, Mizukami K, Okimoto T, Kodama M, Amano Y, Murakami K. Aerosols Produced by Upper Gastrointestinal Endoscopy: A Quantitative Evaluation. Am J Gastroenterol. 2021 Jan 1;11 — View Citation

Somsen GA, van Rijn CJM, Kooij S, Bem RA, Bonn D. Measurement of small droplet aerosol concentrations in public spaces using handheld particle counters. Phys Fluids (1994). 2020 Dec 1;32(12):121707. doi: 10.1063/5.0035701. — View Citation

Yu IT, Li Y, Wong TW, Tam W, Chan AT, Lee JH, Leung DY, Ho T. Evidence of airborne transmission of the severe acute respiratory syndrome virus. N Engl J Med. 2004 Apr 22;350(17):1731-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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