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

Sponsor
King Chulalongkorn Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04981535
Collaborator
(none)
250
1
2
9
27.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Head box during upper gastrointestinal endoscopy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 30, 2021
Actual Primary Completion Date :
Dec 24, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients undergoing upper gastrointestinal endoscopy with head box

experimental group

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

No Intervention: Patients undergoing upper gastrointestinal endoscopy without head box

standard of care group

Outcome Measures

Primary Outcome Measures

  1. The amount of aerosol particles measured on the face of th endoscopist performing an upper gastrointestinal endoscopy [5 months]

    Aerosol particles measured by portable particle counter as count per cubic foot

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 King Chulalongkorn Memorial Hospital Bangkok Thailand 10330

Sponsors and Collaborators

  • King Chulalongkorn Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rapat Pittayanon, Associate Professor, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04981535
Other Study ID Numbers:
  • RP022
First Posted:
Jul 29, 2021
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rapat Pittayanon, Associate Professor, King Chulalongkorn Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022