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Efficacy of PLEM100(Inbody®) in Children

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ClinicalTrials.gov Identifier: NCT03195686
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

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

Condition or disease Intervention/treatment
Development, Child Device: PLE100(Inbody®)

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).


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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy of PLEM100(Inbody®) to Measure the the Sedation Level in Pediatric Patients
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : July 29, 2018
Actual Study Completion Date : July 30, 2018

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


Primary Outcome Measures :
  1. PLE100 score (0 to 100) [ Time Frame: baseline and end of surgery ]
    Changes of PLE100 score


Secondary Outcome Measures :
  1. 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

  2. pharmacodynamic model [ Time Frame: baseline and end of surgery ]
    UMSS with propofol concentration



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195686


Locations
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Korea, Republic of
Hee-Soo Kim
Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee-Soo Kim, PhD Seoul National University Hospital

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Responsible Party: Hee-Soo Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03195686     History of Changes
Other Study ID Numbers: 1795-110-855
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No