Position of EGD in Droplet Spreading

The Comparison of Left Lateral Versus Prone Position in Saliva Droplet Spreading During Upper Gastrointestinal Endoscopy; a Pilot Study of Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Cotamination on Face Shield
• Intervention / Treatment: Other: Left lateral Position during intervention; Other: Prone Position during intervention

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of adenosine triphosphate (ATP) on face shield of endoscopist	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.	immediately following the procedure

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: March 28, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: RP017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Do not plan for data sharing due to the privacy of each patient.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No