Patients Undergoing Diagnostic EGD
Conditions
Keywords
water exchange, upper endoscopy, discomfort
Brief summary
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.
Interventions
PROCEDUREGastric water exchange
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.
PROCEDUREtraditional air insufflation
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.
Sponsors
Yu-Hsi hsieh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort during the procedure | 5 minutes after the procedure | A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction score | 5 minutes after the procedure | A VAS score (0, not satisfied at all; 10, most satisfied) graded by the patient |
| mucosa cleanliness score | 1 minutes after the procedure | 1, no need for irrigation; 4, need more than 50 ml of water irrigation |
| technique adequacy score | 1 minutes after the procedure | 1, excellent; 6, very poor |
Countries
Taiwan
Contacts
Primary ContactYu-Hsi Hsieh, MD
Outcome results
None listed