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Efficacy of PLEM100(Inbody®) in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 18, 2017
First Posted Date June 22, 2017
Last Update Posted Date November 14, 2018
Actual Study Start Date August 15, 2017
Actual Primary Completion Date July 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 10, 2018)
PLE100 score (0 to 100) [ Time Frame: baseline and end of surgery ]
Changes of PLE100 score
Original Primary Outcome Measures
 (submitted: June 19, 2017)
PLE100 score (0 to 100) [ Time Frame: From 1 minute before administration of propofol to the end of anesthesia ]
Changes of PLE100 score
Change History Complete list of historical versions of study NCT03195686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 10, 2018)
  • 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
  • pharmacodynamic model [ Time Frame: baseline and end of surgery ]
    UMSS with propofol concentration
Original Secondary Outcome Measures
 (submitted: June 19, 2017)
The level of consciousness measured in University of Michigan Sedation Scale (UMSS) [ Time Frame: From 1 minute before administration of propofol to the end of anesthesia ]
correlation with the PLE100 scores
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy of PLEM100(Inbody®) in Children
Official Title Efficacy of PLEM100(Inbody®) to Measure the the Sedation Level in Pediatric Patients
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).

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years
Condition Development, Child
Intervention Device: PLE100(Inbody®)
PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 30, 2018)
60
Original Estimated Enrollment
 (submitted: June 19, 2017)
30
Actual Study Completion Date July 30, 2018
Actual Primary Completion Date July 29, 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 6 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03195686
Other Study ID Numbers 1795-110-855
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Hee-Soo Kim, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Hee-Soo Kim, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date November 2018