Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients

NCT06842602 | Completed

• 1 other identifier: 2023/07-11
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Gastroscopy

Keywords

gastric pH; gastric residual volume; gastroscopy; candy; gum; preoperative fasting rules

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• endoscopist satisfaction

  baseline

• general procedure satisfaction

  baseline

• Complication

  Perioperative

Study Arms (3)

Group control

ACTIVE COMPARATOR

strict fasting rules

Other: strict fasting rules

Group gum

ACTIVE COMPARATOR

chewed gum within 2 hours before the procedure

Other: gum

Group candy

ACTIVE COMPARATOR

consumed candy within 2 hours before the procedure

Other: candy

Interventions

gum OTHER

chewed gum within 2 hours before the procedure

Group gum

candy OTHER

consumed candy within 2 hours before the procedure

Group candy

strict fasting rules OTHER

followed strict fasting rules

Group control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Mehmet Fatih Erol

Bursa, 16400, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Chewing Gum; Candy

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mehmet fatih erol, M.D

  Bursa Yuksek ıhtısas tra

  STUDY DIRECTOR

• Füsun gözen, M.D

  Bursa Yuksek Ihtısas tranin and research hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: m.d

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: January 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: January 1, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

TU (1)