Efficacy of PLEM100(Inbody®) in Children

November 9, 2018 updated by: Hee-Soo Kim, Seoul National University Hospital

Efficacy of PLEM100(Inbody®) to Measure the the Sedation Level in Pediatric Patients

Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators plan to gather the basic data relevant to measurement of the level of consciousness/sedation in pediatric patients with developing brain by using PLEM100(Inbody®)

PLEM100 (Inbody®) is a medical equipment to measure, based on phase lag entropy algorithm, the level of patient consciousness, which is expressed by PLE score ranging from 0 (burst suppression or deep sedated) to 100 (awake).

In this study, pediatric patients aged from 3 to 6 years old who undergo total intravenous general anesthesia are chosen as target subjects. The investigators measure how PLE score changes during 1) anesthesia induction, 2) anesthesia maintenance, 3) emergence from anesthesia. Then, the PLE score would be validated by analyzing the correlation with the consciousness level expressed in University of Michigan Sedation Scale (UMSS).

Study Type

Observational

Enrollment (Actual)

60

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
    • Soul-t'ukpyolsi
      • Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
        • Hee-Soo Kim

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

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years

Description

Inclusion Criteria:

  • Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years
  • Written Consent is available from a parent who has been explained about the study
  • Elective surgery

Exclusion Criteria:

  • Patients who cannot be attached by PLEM100 (Inbody®) sensors to the forehead or the side of the head
  • Patients Having Cerebral Vascular Diseases in the past or present
  • Patients with Developmental delay
  • Patients to be admitted to intensive care unit or sedated after receiving operation
  • Patients who researchers decide are not eligible to be enrolled in the study because of various factors including clinical test results.

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
PLE100 score (0 to 100)
Time Frame: baseline and end of surgery
Changes of PLE100 score
baseline and end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of consciousness measured in University of Michigan Sedation Scale (UMSS)
Time Frame: baseline and end of surgery
correlation with the PLE100 scores and concentraion of propofol
baseline and end of surgery
pharmacodynamic model
Time Frame: baseline and end of surgery
UMSS with propofol concentration
baseline and end of surgery

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)

August 15, 2017

Primary Completion (ACTUAL)

July 29, 2018

Study Completion (ACTUAL)

July 30, 2018

Study Registration Dates

First Submitted

June 18, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (ACTUAL)

June 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1795-110-855

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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