Efficacy of PLEM100(Inbody®) in Children | NCT03195686

Studies
Efficacy of PLEM100(Inbody®) in Children

NCT03195686

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Nov 14, 2018Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Development, Child

Interventions

PLE100(Inbody®)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2017Actual

Primary Completion Date

Jul 29, 2018Actual

Completion Date

Jul 30, 2018Actual

First Submitted Date

Jun 18, 2017

First Submission Date that Met QC Criteria

Jun 19, 2017

First Posted Date

Jun 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2018

Last Update Posted Date

Nov 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PLE100(Inbody®)	Device	PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hee-Soo Kim, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hee-Soo Kim		Seoul	Soul-t'ukpyolsi	03080	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34503455	Derived	Jang YE, Ji SH, Lee JH, Kim EH, Kim JT, Kim HS. The relationship between the effect-site concentration of propofol and sedation scale in children: a pharmacodynamic modeling study. BMC Anesthesiol. 2021 Sep 9;21(1):222. doi: 10.1186/s12871-021-01446-y.