Identification of Changes in Gastric Volume and Content by Ultrasound Before and After Chewing Gum

NCT ID: NCT02852863

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-10-31

Brief Summary

To identify by ultrasound the possible changes in gastric volume and content after chewing gum for an hour in volunteers with complete fasting (more than 8 hours).

Conditions

Gastric Volume

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ultrasound (case only)

Subjects will fast for a minimum of 8 hours. Ultrasound assessment of gastric volume and content will determine basal conditions. Next, subjects will chew gum for one hour with changes of gum every 20 minutes (a total of 3 gums will be chewed per subject). Once the last gum is chewed, the gum will be disposed in the trashcan. Three more ultrasound assessments will take place: immediately after one hour of chewing gum, and at the first and second hour after chewing gum has stopped. The content will be classified as empty, with fluids, or with solid. In case of fluids, volume will be measured.

Group Type: EXPERIMENTAL

Gum

Intervention Type: OTHER

Subjects will fast for a minimum of 8 hours. A baseline ultrasound assesment will be performed to evaluate gastric content. Next, subjects will chew sugarless gum for one hour with changes of gum every 20 minutes (a total of 3 gums will be chewed per subject). Once the last gum is chewed, the gum will be disposed in the trashcan. Three more ultrasound assessments will take place: immediately after one hour of chewing gum, and at the first and second hour after chewing gum has stopped. The content will be classified as empty, with fluids, or with solid. In case of fluids, volume will be measured.

Interventions

Gum

Subjects will fast for a minimum of 8 hours. A baseline ultrasound assesment will be performed to evaluate gastric content. Next, subjects will chew sugarless gum for one hour with changes of gum every 20 minutes (a total of 3 gums will be chewed per subject). Once the last gum is chewed, the gum will be disposed in the trashcan. Three more ultrasound assessments will take place: immediately after one hour of chewing gum, and at the first and second hour after chewing gum has stopped. The content will be classified as empty, with fluids, or with solid. In case of fluids, volume will be measured.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adults older or equal than 18 years old
• Minimum of 8 hours of fasting
• must work/study at Fundacion Santa Fe

Exclusion Criteria

• Comorbidities such as obesity, renal failure, diabetes
• Gastrointestinal Disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación Santa Fe de Bogota

OTHER

Sponsor Role: lead

Responsible Party

Jose Alejandro Valencia

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Fundacion SantaFe de Bogota

Bogotá, Bogota D.C., Colombia

Countries

Colombia

Other Identifiers

CCEI-5523-2016

Identifier Type: -

Identifier Source: org_study_id