NCT03195686

Efficacy of PLEM100(Inbody®) in Children

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Development, Child

Interventions

Type	Name	Description
DEVICE	PLE100(Inbody®)	PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)

Timeline

• Start date: 2017-08-15
• Primary completion: 2018-07-29
• Completion: 2018-07-30
• First posted: 2017-06-22
• Last updated: 2018-11-14

Locations

1 site across 1 country: South Korea