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

Gastric Volume Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852863
• Other study ID #: CCEI-5523-2016
• Status: Completed
• Phase: N/A
• First received: July 26, 2016
• Last updated: March 21, 2017
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: Fundación Santa Fe de Bogota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Volume

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Colombia	Hospital Universitario Fundacion SantaFe de Bogota	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Santa Fe de Bogota

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric volume change in mL		2 hours