Neurophysiologic MonitoringNCT05963256
Prediction Model for TOF
An observational study of Neurophysiologic Monitoring, run by Eunah Cho, MD at 1 site in South Korea.
Trial summary
This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50% in patients undergoing neurosurgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurophysiologic Monitoring
- What is being tested?
- Twitch Electrode Array
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2023to 20 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing neurosurgery
Who may be able to join
- patient undergoing neurosurgery
- scheduled for intra-operative neurophysiological monitoring
- American Society of Anesthesiologists physical class I, II, III
Who cannot join
- unable to monitor train-of-four
- decline to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Eunah Cho
Seoul, 03181
Eunah Cho, PhD, 821094800531, mintflavored@naver.com
About this study
Official title: Investigation for Development of Predictive Model for Train of Four (TOF)% for Neurophysiological Monitoring During Neuroanesthesia
This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50% in patients undergoing neurosurgery.
- Conditions
- Neurophysiologic Monitoring
- Being tested
- Twitch Electrode Array
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twitch Electrode ArrayDevice
Monitor train-of-four (TOF) count and percentage
What is being measured
The primary outcome is the main question the study is designed to answer.
Train-of-four (TOF) ratio
The ratio of the height of the fourth muscle response to the first one following the nerve stimulation
Measured: 30 minutes after reaching the TOF plateau
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start20 Jul 2023
- Primary completion20 Jul 2023
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurophysiologic MonitoringStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunah Cho, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
- Investigators
- Eunah Cho, PhD, Principal investigator, KangbukSamsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963256
- Sponsor's protocol ID
- 2023-01-056
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation for Development of Predictive Model for Train of Four (TOF)% for Neurophysiological Monitoring During Neuroanesthesia
- ClinicalTrials.gov ID
- NCT05963256
- Acronym / sponsor ID
- 2023-01-056
- Conditions
- Neurophysiologic Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Eunah Cho, MDUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 27 Jul 2023 (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.
This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50% in patients undergoing neurosurgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing neurosurgery
Key inclusion criteria (3 listed)
- patient undergoing neurosurgery
- scheduled for intra-operative neurophysiological monitoring
- American Society of Anesthesiologists physical class I, II, III
Key exclusion criteria (2 listed)
- unable to monitor train-of-four
- decline to participate in the study
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 |
|---|---|---|
| Twitch Electrode ArrayMonitor train-of-four (TOF) count and percentage | Device | – |
Primary outcome
Train-of-four (TOF) ratio
Time frame: 30 minutes after reaching the TOF plateau
The ratio of the height of the fourth muscle response to the first one following the nerve stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
Eunah Cho, PhD principal investigator
KangbukSamsung 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 Neurophysiologic Monitoring, run by Eunah Cho, MD 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 2 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunah Cho, PhD (82-10-9480-0531, mintflavored@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Train-of-four (TOF) ratio (time frame: 30 minutes after reaching the TOF plateau). 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 1 Aug 2023.