Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852863
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Jose Alejandro Valencia, Fundación Santa Fe de Bogota

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).

Condition or disease Intervention/treatment Phase
Gastric Volume Other: Gum Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasound Assessment of Changes in Gastric Volume and Content Before and After Chewing Gum
Study Start Date : July 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. Gastric volume change in mL [ Time Frame: 2 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852863


Locations
Layout table for location information
Colombia
Hospital Universitario Fundacion SantaFe de Bogota
Bogota, Colombia
Sponsors and Collaborators
Fundación Santa Fe de Bogota
Layout table for additonal information
Responsible Party: Jose Alejandro Valencia, MD, Fundación Santa Fe de Bogota
ClinicalTrials.gov Identifier: NCT02852863    
Other Study ID Numbers: CCEI-5523-2016
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes