Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients

Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients Using Chewing Gum and Candy: Prospective Randomized Double-Blind Study

Pulmonary aspiration is a rare but serious complication that can result in 57% mortality and 14% permanent damage. Fasting rules (solid foods 6-8 hours, clear liquids 2 hours) determined by anesthesia associations are applied to prevent pulmonary aspiration by reducing gastric volume. Gastric volume (≥ 0.5 mL/kg) and pH (<2.5) values are shown to be determinants in the occurrence of pulmonary complications .

Study Overview

• Status: Completed
• Conditions: Gastroscopy
• Intervention / Treatment: Other: strict fasting rules; Other: gum; Other: candy

Detailed Description

The hypothesis of this study was that preprocedure candy and chewing gum use may have no effects on gastric residual volume and pH. For this purpose, we analyzed the gastric residual volume and gastric pH values of patients who were given gum and candy before the procedure.

• Study Type: Interventional
• Enrollment (Actual): 405
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16400
    • Mehmet Fatih Erol

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• ASA I-III,
• oriented
• cooperative
• scheduled for elective gastroscopy

Exclusion Criteria:

• body mass index is (BMI) >30 kg/m2,
• full stomach predicted patients (obstruction, stenosis, bleeding, ascites, urgency),
• patients with diabetes
• patients with who underwent bowel cleansing
• patients who did not want to give consent to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group control; strict fasting rules	Other: strict fasting rules; followed strict fasting rules
Active Comparator: Group gum; chewed gum within 2 hours before the procedure	Other: gum; chewed gum within 2 hours before the procedure
Active Comparator: Group candy; consumed candy within 2 hours before the procedure	Other: candy; consumed candy within 2 hours before the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric volume	No washing was performed during the insertion and advancement of the endoscope. The entire gastric volume were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded .	baseline
Gastric pH measurements	No washing was performed during the insertion and advancement of the endoscope. The entire gastric contents were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded and pH analysis (WTW inoLab® pH 7310 Table Type pH Meter) was performed.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endoscopist satisfaction	At the end of the procedure, endoscopist satisfaction (0=unsatisfied 1=abstained 2=satisfied) and procedure difficulty (0=easy 1=normal 2=difficult)	baseline
general procedure satisfaction	Before discharge, general procedure satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product effects (1=increase in hunger, 2=increase in thirst, 3=increase in dyspepsia, 4=abstained, 5= decrease in hunger, 6= decrease in thirst, 7= decrease in dyspepsia)	baseline
Complication		Perioperative

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Study Director: Mehmet fatih erol, M.D, Bursa Yuksek ıhtısas tra; Study Director: Füsun gözen, M.D, Bursa Yuksek Ihtısas tranin and research hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: gastroscopy; gastric residual volume; gastric pH; gum; candy; preoperative fasting rules
• Other Study ID Numbers: 2023/07-11

Drug and device information, study documents

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