Estimation of Preoperative Gastric Volume Using Ultrasound (GUS)

February 3, 2021 updated by: Jin-Tae Kim, Seoul National University Hospital

Ultrasound Assessment of Gastric Volume in Infants Undergoing General Anesthesia: Validation Study

Aspiration of gastric contents can be a serious anesthetic related complication. Gastric antral sonography prior to anesthesia may have a role in identifying pediatric patients at risk of aspiration. The investigator examined the relationship between sonographic antral area and endoscopically suctioned gastric volumes infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

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

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

No older than 2 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants undergoing general anesthesia for abdominal surgery

Description

Inclusion Criteria:

  • Infants undergoing general anesthesia with endotracheal intubation were included in this study

Exclusion Criteria:

  • a recent (≤1 month) history of oesophageal or gastric surgery, gastrostomy or ileostomy, diaphragmatic hernia, emergent surgery, or a prolonged duration (>5 min) between completion of US assessment and suctioning of gastric contents

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GUS_infants
Infants patient undergoing general anesthesia for abdominal surgery
Diagnostic test: GUS
gastric volume estimation using gastric ultrasound was performed immediately after anesthetic induction, and after aspirating the residual gastric contents using nasogastric tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastric antral cross sectional area
Time Frame: immediate after anesthetic induction within 1 minutes.
ultrasound assessment of gastric antral cross sectional area
immediate after anesthetic induction within 1 minutes.

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 15, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • H 1703-183-843

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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