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Position of EGD in Droplet Spreading

Sponsor
King Chulalongkorn Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04329013
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
17.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The association between position of upper gastrointestinal endoscopy (EGD) and saliva droplet spreading has never been studied. In the era of contagious viral spreading, this pilot study is aimed to assess adenosine triphosphate (ATP) at the face shield of endoscopist which can represent the saliva droplet spreading of patients in left lateral and prone position during EGD.

Condition or Disease Intervention/Treatment Phase
  • Other: Left lateral Position during intervention
  • Other: Prone Position during intervention
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
We will randomize the patients who need EGD into 2 groups; left lateral and prone position by block of 4.We will randomize the patients who need EGD into 2 groups; left lateral and prone position by block of 4.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Comparison of Left Lateral Versus Prone Position in Saliva Droplet Spreading During Upper Gastrointestinal Endoscopy; a Pilot Study of Randomized Trial
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Left lateral position

The patient will be in left lateral position during EGD

Other: Left lateral Position during intervention
Left lateral position during EGD
Experimental: Prone position

The patient will be in prone position during EGD

Other: Prone Position during intervention
Prone position during EGD

Outcome Measures

Primary Outcome Measures

  1. The level of adenosine triphosphate (ATP) on face shield of endoscopist [immediately following the procedure]

    Measuring the ATP on face shield of endoscopist by using ATP luminometer. It is measured in relative light unit (RLU). The level of ATP is concordant with the level of bacteria on that measuring object.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who have the indication for upper gastrointestinal endoscopy
Exclusion Criteria:

  • Cannot be in prone position

  • The endoscopist deny the assigned position in any reason.

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, Principle investigator, Gastrointestinal Unit, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04329013
Other Study ID Numbers:
  • RP017
First Posted:
Apr 1, 2020
Last Update Posted:
Dec 7, 2020
Last Verified:
Dec 1, 2020
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

Study Results

No Results Posted as of Dec 7, 2020