Efficacy of PLEM100(Inbody®) in Children

Development, Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195686
• Other study ID #: 1795-110-855
• Status: Completed
• Start date: August 15, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: November 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2018
• Est. primary completion date: July 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Development, Child

Intervention

Device:
• PLE100(Inbody®)
PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)

Locations

Country	Name	City	State
Korea, Republic of	Hee-Soo Kim	Seoul	Soul-t'ukpyolsi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PLE100 score (0 to 100)	Changes of PLE100 score	baseline and end of surgery
Secondary	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
Secondary	pharmacodynamic model	UMSS with propofol concentration	baseline and end of surgery