Depth of AnesthesiaNCT03303443
Empirical Mode Decomposition in the Electroencephalogram
An observational study of Depth of Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Bispectral index (BIS), a standard monitor for perioperative monitor of patient's conscious level, is a noninvasive medical technique for monitoring and recording the electrical activity of brain. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Depth of Anesthesia
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2016to 15 Jun 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20-40y/o patients or over 60y/o patients without severe systemic disease who were scheduled for general anesthesia.
Who may be able to join
- 20-40y/o or over 60y/o
- Scheduled for low risk general anesthesia
- Suitable for surgery after interviewed by anesthesiologist
Who cannot join
- Not suitable for general anesthesia
- High risk patient
- Allergic to the EEG sensor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empirical Mode Decomposition in the Electroencephalogram During General Anesthesia Between Generations
Bispectral index (BIS), a standard monitor for perioperative monitor of patient's conscious level, is a noninvasive medical technique for monitoring and recording the electrical activity of brain.
Read the detailed description
The electroencephalogram and BIS data have lots of information. Fourier transformation to decompose EEG was first applied on the EEG signaling until now. The disadvantages of Fourier transformation is hard to deal with physical signals, which was modulated by autonomic system and factors. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF) since 2004. HHT can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear. HHT have been applied for wild ranges, not only in the analysis of arrhythmia for medical and public health fields, but also in the earthquake detection and earth physics detection…etc.
The relationship between frontal EEG patterns and general anesthesia remain poorly understood. It can only say that the increase in frontal EEG power and shift power to lower frequencies during general anesthesia from publications. The investigators are going to compare the EEG signal between generations, try to find the difference in aging using empirical mode decomposition method.
- Conditions
- Depth of Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Younger | 20-40 years old patients | |
| Elderly | over 60 years old patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG power calculation
The investigator use root mean square energy to calculate EEG power.
Measured: During the operation time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start15 May 2016
- Primary completion15 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depth of AnesthesiaStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng-Fang Tsai, MD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303443
- Sponsor's protocol ID
- 201508007RIN
- Status last verified
- Apr 2019
- First submitted
- 1 Dec 2015
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Mode Decomposition in the Electroencephalogram During General Anesthesia Between Generations
- ClinicalTrials.gov ID
- NCT03303443
- Acronym / sponsor ID
- 201508007RIN
- Conditions
- Depth of Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 6 Oct 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.
Bispectral index (BIS), a standard monitor for perioperative monitor of patient's conscious level, is a noninvasive medical technique for monitoring and recording the electrical activity of brain.
Detailed description
The electroencephalogram and BIS data have lots of information. Fourier transformation to decompose EEG was first applied on the EEG signaling until now. The disadvantages of Fourier transformation is hard to deal with physical signals, which was modulated by autonomic system and factors. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF) since 2004. HHT can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear. HHT have been applied for wild ranges, not only in the analysis of arrhythmia for medical and public health fields, but also in the earthquake detection and earth physics detection…etc.
The relationship between frontal EEG patterns and general anesthesia remain poorly understood. It can only say that the increase in frontal EEG power and shift power to lower frequencies during general anesthesia from publications. The investigators are going to compare the EEG signal between generations, try to find the difference in aging using empirical mode decomposition method.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger | – | –20-40 years old patients |
| Elderly | – | –over 60 years old patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20-40y/o patients or over 60y/o patients without severe systemic disease who were scheduled for general anesthesia.
Key inclusion criteria (3 listed)
- 20-40y/o or over 60y/o
- Scheduled for low risk general anesthesia
- Suitable for surgery after interviewed by anesthesiologist
Key exclusion criteria (3 listed)
- Not suitable for general anesthesia
- High risk patient
- Allergic to the EEG sensor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EEG power calculation
Time frame: During the operation time.
The investigator use root mean square energy to calculate EEG power.
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 5 Jun 2020.
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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.
Feng-Fang Tsai, MD study chair
National Taiwan 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 Depth of Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 5 Jun 2020. 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 Taiwan. 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?
EEG power calculation (time frame: During the operation time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2020.