Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients

June 7, 2021 updated by: JiWon Han, Seoul National University Bundang Hospital

Ultrasound Assessment of Gastric Volume and Aspiration Risk Evaluation in the Fasted Pediatric Cerebral Palsy Patients

In children with cerebral palsy, the gastric volume is measured through ultrasound after fasting before surgery to evaluate whether the risk of aspiration is higher than that of the general population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

38

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia

Description

Inclusion Criteria:

  • Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia

Exclusion Criteria:

  • Levin tube or gastrostomy tube in situ
  • Decline to participate

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastric volume
Time Frame: preoperative 1 days to postoperative 1 days
Volume = -7.8 + (3.5 x RLD CSA) + 0.127 X age (months)
preoperative 1 days to postoperative 1 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of gastric fullness
Time Frame: preoperative 1 days to postoperative 1 days
Grade 0: Neither in supine, right lateral decubitus / Grade 1: stomach content only in lateral decubitus , Grade 2: Both in supine, lateral decubitus
preoperative 1 days to postoperative 1 days

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang 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 (Anticipated)

June 5, 2021

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-2021-365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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