Prediction Model for TOF | NCT05963256

Studies
Prediction Model for TOF

NCT05963256

Sponsor

Eunah Cho, MD

Status

Unknown status

Last Update Posted

Aug 1, 2023Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Neurophysiologic Monitoring

Interventions

Twitch Electrode Array

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2023Actual

Primary Completion Date

Jul 20, 2023Actual

Completion Date

Jul 20, 2024Estimated

First Submitted Date

Jul 19, 2023

First Submission Date that Met QC Criteria

Jul 19, 2023

First Posted Date

Jul 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2023

Last Update Posted Date

Aug 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50% in patients undergoing neurosurgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Twitch Electrode Array	Device	Monitor train-of-four (TOF) count and percentage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Train-of-four (TOF) ratio	The ratio of the height of the fourth muscle response to the first one following the nerve stimulation	30 minutes after reaching the TOF plateau

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient undergoing neurosurgery
scheduled for intra-operative neurophysiological monitoring
American Society of Anesthesiologists physical class I, II, III

Exclusion Criteria:

unable to monitor train-of-four
decline to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient undergoing neurosurgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eunah Cho, PhD	Contact	82-10-9480-0531		mintflavored@naver.com

Overall Officials

Name	Affiliation	Role
Eunah Cho, PhD	KangbukSamsung Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eunah Cho	Recruiting	Seoul		03181	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided