UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056552 |
|---|---|
| Receipt number | R000064623 |
| Scientific Title | Performance of Electroencephalogram Analysis Using the Hilbert-Huang Transform in Detecting Cerebral Ischemia |
| Date of disclosure of the study information | 2024/12/24 |
| Last modified on | 2025/12/27 10:55:12 |
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Basic information
Public title
Performance of Electroencephalogram Analysis Using the Hilbert-Huang Transform in Detecting Cerebral Ischemia
Acronym
Performance of Electroencephalogram Analysis Using the Hilbert-Huang Transform in Detecting Cerebral Ischemia
Scientific Title
Performance of Electroencephalogram Analysis Using the Hilbert-Huang Transform in Detecting Cerebral Ischemia
Scientific Title:Acronym
Performance of Electroencephalogram Analysis Using the Hilbert-Huang Transform in Detecting Cerebral Ischemia
Region
| Japan |
Condition
Condition
Adult patients underwent transcatheter aortic valve replacement under general anesthesia, who measured frontal electroencephalogram using the BIS brain monitoring system and experienced transient cerebral ischemia induced by rapid ventricular pacing for ensuring cardiac standstill during the procedure
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the efficacy of electroencephalogram analysis using the Hilbert-Huang Transform, a method specifically designed for nonlinear and nonstationary data, offering enhanced time-frequency resolution compared to traditional methods, in detecting cerebral ischemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Specificity, rapidity, and interpretability of the Hilbert-Huang Transform for electroencephalogram analysis in detecting cerebral ischemia
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients underwent transcatheter aortic valve replacement under general anesthesia, who measured frontal electroencephalogram using the BIS brain monitoring system and experienced transient cerebral ischemia induced by rapid ventricular pacing for ensuring cardiac standstill during the procedure
Key exclusion criteria
Patients with missing data or artifacts in their electroencephalogram recordings
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kanji |
| Middle name | |
| Last name | Uchida |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology and Pain Relief Center
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8668
uchidak-ane@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Wakabayashi |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology and Pain Relief Center
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
0358008668
Homepage URL
wakabayashir@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
0358410818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observation period was set from 30 seconds before the start of rapid ventricular pacing to 60 seconds after. Numerical data recorded every 3 seconds and waveform data captured at a sampling rate of 250 Hz were used for analysis. The electroencephalogram data were analyzed using the Hilbert-Huang Transform to compute the instantaneous energy for each frequency band. In addition, the same electroencephalogram waveforms were also analyzed using a multitaper-based time-frequency approach, and spectral indices including the 95% spectral edge frequency were evaluated.
Management information
Registered date
| 2024 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064623
