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CompletedNCT04981535Updated Nov 14, 2022

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

An interventional study of Head box during upper gastrointestinal endoscopy in EGD, Covid19 and Aerosol Disease, sponsored by King Chulalongkorn Memorial Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by King Chulalongkorn Memorial Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • EGD
  • Covid19
  • Aerosol Disease
  • Head Box

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Keywords

  • Upper gastrointestinal endoscopy
  • EGD
  • COVID-19
  • Aerosol-generating procedure
  • Head box
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 190 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

King Chulalongkorn Memorial Hospital is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
190 participants (actual)

Study arms

  • Experimental
    Patients undergoing upper gastrointestinal endoscopy with head box

    experimental group

    Device: Head box during upper gastrointestinal endoscopy

  • No intervention
    Patients undergoing upper gastrointestinal endoscopy without head box

    standard of care group

Interventions

  • DeviceHead box during upper gastrointestinal endoscopy

    "็Head box" is an acrylic box over a patient's head who undergoing upper gastrointestinal endoscopy.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 months

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Study locations

1 site
  • King Chulalongkorn Memorial Hospital
    Bangkok, 10330, Thailand
08

References and documents

Publications

  • 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. PubMed 32294374 ↗
  • 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. PubMed 32437712 ↗
  • 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. PubMed 15102999 ↗
  • 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. PubMed 33362399 ↗
  • 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. PubMed 32649933 ↗
  • 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. PubMed 33079747 ↗
  • 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. PubMed 34187844 ↗
  • 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. PubMed 33506983 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04981535
Lead sponsor
King Chulalongkorn Memorial Hospital
Responsible party
Rapat Pittayanon (Associate Professor, King Chulalongkorn Memorial Hospital) — Principal investigator
First posted
Jul 29, 2021
Start date
Sep 30, 2021
Primary completion
Dec 24, 2021
Completion
Jun 30, 2022
Last update
Nov 14, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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