Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy

Study Overview
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Brief Summary
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The aim of the study was to evaluate the application of water exchange method to upper endoscopy. We hypothesize that water exchange during upper endoscopy could reduce patient discomfort. The primary outcome will be the patient discomfort score during upper endoscopy. The secondary outcomes will include cleanliness score, techniques adequacy score, findings of the EGD, and willing to repeat the procedure, as well as the patient and endoscopist satisfaction score with the method.

Official Title
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Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy

Conditions
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Patients Undergoing Diagnostic EGD

Intervention / Treatment
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* Procedure: Gastric water exchange
* Procedure: traditional air insufflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the time of enrollment Exclusion Criteria: a therapeutic EGD sedation with other agents American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure age less than 20 years or more than 65 years pregnancy refusal to provide written informed consent. All participants signed written informed consents

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric water exchange<br>Air will be minimally insufflated to partially open the lumen and any residual fluid will be suctioned when the scope passes through the esophagus. Upon entering the fundus of the stomach the air button will be turned off. Air pocket and gastric fluids will be removed by suctioning. Distilled water, delivered by a 50-ml syringe in 10ml-to-20 ml increments, will be infused to dislodge debris and air bubbles adhering the gastric mucosa and open the lumen. The infused water will be removed to keep the lumen almost completely collapsed before the scope advance further. Air will be opened when the scope enter the prepylorus area where there is usually an air pocket. The scope will enter the duodenal bulb and 2nd portion of duodenum where withdrawal inspection will start. | Procedure: Gastric water exchange<br>* Upon entering the fundus of the stomach the air button will be turned off. Air pocket and gastric fluids will be removed by suctioning. Distilled water, delivered by a 50-ml syringe in 10ml-to-20 ml increments, will be infused to dislodge debris and air bubbles adhering the gastric mucosa and open the lumen. The infused water will be removed to keep the lumen almost completely collapsed before the scope advance further.<br>|
| Active Comparator: Traditional air insufflation<br>Air will be minimally insufflated and residual fluid suctioned during the entire insertion process. Usually, no water will be infused to cleanse the mucosa until the withdrawal phase. | Procedure: traditional air insufflation<br>* Air will be minimally insufflated and residual fluid suctioned during the entire insertion process. Usually, no water will be infused to cleanse the mucosa until the withdrawal phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort during the procedure | A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient, | 5 minutes after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction score | A VAS score (0, not satisfied at all; 10, most satisfied) graded by the patient | 5 minutes after the procedure | 
| mucosa cleanliness score | 1, no need for irrigation; 4, need more than 50 ml of water irrigation | 1 minutes after the procedure | 
| technique adequacy score | 1, excellent; 6, very poor | 1 minutes after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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water exchange, upper endoscopy, discomfort