Ultrasound Assessment of Preoperative Gastric Volume in Children

September 17, 2020 updated by: Jin-Tae Kim, Seoul National University Hospital

Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients

The purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

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 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Pediatric patients scheduled for elective orthopedic, otolaryngologic, ophthalmologic, plastic, and urologic surgery under general anesthesia

Exclusion Criteria:

  • History of surgery on the esophagus or stomach
  • History of gastrointestinal disease
  • Ambulatory surgery
  • Considered inappropriate by the investigator

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infant formula
Patients were given infant formula 6 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.
Other: General anesthesia
Scheduled operation under general anesthesia
Device: Ultrasound
Ultrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia.
Experimental: Carbohydrate drink
Patients were given carbohydrate drink 2 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.
Other: General anesthesia
Scheduled operation under general anesthesia
Device: Ultrasound
Ultrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intra-group difference between gastric volume measured on second and third ultrasound assessment
Time Frame: Interval between second and third ultrasound assessment, an expected average of 1 hour
Interval between second and third ultrasound assessment, an expected average of 1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Inter-group difference in gastric volume at each time point
Time Frame: From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours
From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours
Perioperative incidence of nausea, vomiting, fever, and respiratory complications
Time Frame: From the induction of general anesthesia until postoperative 24 hours
From the induction of general anesthesia until postoperative 24 hours
Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad
Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad
Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad
Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad
Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad
Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad
Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied
Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours

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 12, 2017

Primary Completion (Actual)

April 20, 2019

Study Completion (Actual)

April 20, 2019

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1612100815

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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