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

NCT04981535 | Completed DMC

• 1 other identifier: RP022
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

EGD; Covid19; Aerosol Disease; Head Box

Keywords

Upper gastrointestinal endoscopy; EGD; COVID-19; Aerosol-generating procedure; Head box

Outcome Measures

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

  5 months

Study Arms (2)

Patients undergoing upper gastrointestinal endoscopy with head box

EXPERIMENTAL

experimental group

Device: Head box during upper gastrointestinal endoscopy

Patients undergoing upper gastrointestinal endoscopy without head box

NO INTERVENTION

standard of care group

Interventions

Head box during upper gastrointestinal endoscopy DEVICE

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

Patients undergoing upper gastrointestinal endoscopy with head box

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Related Publications (8)

• 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.

  PMID: 32294374 RESULT

• 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.

  PMID: 32437712 RESULT

• 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.

  PMID: 15102999 RESULT

• 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.

  PMID: 33362399 RESULT

• 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.

  PMID: 32649933 RESULT

• 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.

  PMID: 33079747 RESULT

• 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.

  PMID: 34187844 RESULT

• 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.

  PMID: 33506983 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: September 30, 2021
• Primary Completion: December 24, 2021
• Study Completion: June 30, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)