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

March 21, 2017 updated by: Jose Alejandro Valencia, Fundación Santa Fe de Bogota

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia
        • Hospital Universitario Fundacion SantaFe de Bogota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastric volume change in mL
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Santa Fe de Bogota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CCEI-5523-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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