Aerosol Particle From EGD in Patients With and Without Head Box in COVID-19 Era
Primary Purpose
EGD, Covid19, Aerosol Disease
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Head box during upper gastrointestinal endoscopy
Sponsored by
About this trial
This is an interventional treatment trial for EGD focused on measuring Upper gastrointestinal endoscopy, EGD, COVID-19, Aerosol-generating procedure, Head box
Eligibility Criteria
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
Sites / Locations
- King Chulalongkorn Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patients undergoing upper gastrointestinal endoscopy with head box
Patients undergoing upper gastrointestinal endoscopy without head box
Arm Description
experimental group
standard of care group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04981535
First Posted
July 19, 2021
Last Updated
November 11, 2022
Sponsor
King Chulalongkorn Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04981535
Brief Title
Aerosol Particle From EGD in Patients With and Without Head Box in COVID-19 Era
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EGD, Covid19, Aerosol Disease, Head Box
Keywords
Upper gastrointestinal endoscopy, EGD, COVID-19, Aerosol-generating procedure, Head box
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing upper gastrointestinal endoscopy with head box
Arm Type
Experimental
Arm Description
experimental group
Arm Title
Patients undergoing upper gastrointestinal endoscopy without head box
Arm Type
No Intervention
Arm Description
standard of care group
Intervention Type
Device
Intervention Name(s)
Head box during upper gastrointestinal endoscopy
Intervention Description
"็Head box" is an acrylic box over a patient's head who undergoing upper gastrointestinal endoscopy.
Primary Outcome Measure Information:
Title
The amount of aerosol particles measured on the face of th endoscopist performing an upper gastrointestinal endoscopy
Description
Aerosol particles measured by portable particle counter as count per cubic foot
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32294374
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. No abstract available.
Results Reference
result
PubMed Identifier
32437712
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 2020 May 11. No abstract available.
Results Reference
result
PubMed Identifier
15102999
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. doi: 10.1056/NEJMoa032867.
Results Reference
result
PubMed Identifier
33362399
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.
Results Reference
result
PubMed Identifier
32649933
Citation
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 Nov;159(5):1949-1951.e4. doi: 10.1053/j.gastro.2020.07.002. Epub 2020 Jul 7. No abstract available.
Results Reference
result
PubMed Identifier
33079747
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;116(1):202-205. doi: 10.14309/ajg.0000000000000983.
Results Reference
result
PubMed Identifier
34187844
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: 10.1136/gutjnl-2021-324588. Epub 2021 Jun 29.
Results Reference
result
PubMed Identifier
33506983
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 Gastroenterol Hepatol. 2021 Jul;36(7):1913-1919. doi: 10.1111/jgh.15416. Epub 2021 Feb 18.
Results Reference
result
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Aerosol Particle From EGD in Patients With and Without Head Box in COVID-19 Era
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