Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy

May 19, 2019 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
Investigators assess the gastric contents by ultrasonography in fasted patients undergoing cholecystectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators evaluate the gastric volume through cross sectional area and amount of clear fluid using Perlas grade by ultrasound in the supine and right lateral position of fasted patients undergoing cholecystectomy. Full stomach is regarded if solid gastric contents are detected or clear fluid is more than 1.5 ml/kg. The frequency of full stomach will be analyzed.

Study Type

Observational

Enrollment (Actual)

140

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, 156-707
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for cholecystectomy are included.

Description

Inclusion Criteria:

  • Patients scheduled for cholecystectomy

Exclusion Criteria:

  • Presence of gastric anatomic abnormality or pathology
  • A previous surgery of esophagus or stomach
  • Current pregnancy
  • Who could not lie in the right lateral decubitus (RLD) position

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fasted patients for cholecyctectomy
The fasted patients for cholecyctectomy except exclusion criteria are included
Other: Ultrasound assessment of gastric contet
Ultrasound assessment of gastric content is performed in fasted patient undergoing cholecystectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of full stomach
Time Frame: Before the induction of anesthesia
The incidence of full stomach is assessed by using ultrasonography.
Before the induction of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross sectional area of the stomach
Time Frame: Before the induction of anesthesia
The cross sectional area of the stomach is assessed by using ultrasonography in the supine and right lateral positions.
Before the induction of anesthesia
Volume of stomach
Time Frame: Before the induction of anesthesia
The volume of stomach is assessed using the following formula; volume of stomach (mL) = 27.0 + 14.6 x cross-sectional area (right lateral position) - 1.28 x age.
Before the induction of anesthesia
Type of gastric contents
Time Frame: Before the induction of anesthesia
The type of gastric contents is assessed using ultrasonography.
Before the induction of anesthesia

Collaborators and Investigators

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

Sponsor

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Jin-Young Hwang, M.D., Ph.D., SMG-SNU Boramae Medical Center

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)

October 31, 2017

Primary Completion (Actual)

February 8, 2019

Study Completion (Actual)

February 8, 2019

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 19, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-8-4

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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