Development, ChildNCT03195686
Efficacy of PLEM100(Inbody®) in Children
An observational study of Development, Child, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric patients Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Development, Child
- What is being tested?
- PLE100(Inbody®)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Aug 2017to 30 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of PLEM100(Inbody®) to Measure the the Sedation Level in Pediatric Patients
Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric patients
Read the 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
- Being tested
- PLE100(Inbody®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLE100(Inbody®)Device
PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)
What is being measured
The primary outcome is the main question the study is designed to answer.
PLE100 score (0 to 100)
Changes of PLE100 score
Measured: baseline and end of surgery
Secondary outcomes (2)
The level of consciousness measured in University of Michigan Sedation Scale (UMSS)
correlation with the PLE100 scores and concentraion of propofol
Measured: baseline and end of surgery
pharmacodynamic model
UMSS with propofol concentration
Measured: baseline and end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start15 Aug 2017
- Primary completion29 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Development, ChildStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195686
- Sponsor's protocol ID
- 1795-110-855
- Status last verified
- Nov 2018
- First submitted
- 18 Jun 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34503455
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PLEM100(Inbody®) to Measure the the Sedation Level in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03195686
- Acronym / sponsor ID
- 1795-110-855
- Conditions
- Development, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 29 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLE100(Inbody®)PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol) | Device | – |
Primary outcome
PLE100 score (0 to 100)
Time frame: baseline and end of surgery
Changes of PLE100 score
2 secondary outcomes
The level of consciousness measured in University of Michigan Sedation Scale (UMSS)
Time frame: baseline and end of surgery
pharmacodynamic model
Time frame: baseline and end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Derived from this study: PubMed 34503455Jang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Soo Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development, Child, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PLE100 score (0 to 100) (time frame: baseline and end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.