MedDataX Logo

Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit

NCT ID: NCT02838654

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to analyze the reliability of epidural wave form during cerivical epidural injection.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The epidural space can be confirmed by loss of resistance (LOR) technique. However, LOR has very low specificity, although its sensitivity is high. Especially, cysts between ligaments, clefts in ligamentum flavum, paraspinal muscle and nonspecific spaces between muscles make false LOR.

Epidural wave form analysis (EWA) is very simple and reliable method which can substitue the LOR technique. If the epidural needle is located correctly in the epidural space, the investigators can observe a pulsatile wave and this pulsatile wave corresponds to arterial wave. Generally, sensitivity of EWA through needle is known to be superior to the sensitivity of EWA through catheter and most studies were focused on catheter EWA.

Cervical epidural space shows high false LOR rate and Lee et al demonstrated that false LOR at cervical epidural space was 68.7%. Therefore, nonspecificity of LOR technique require substitution method which can confirm epidural space.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analysis, Event History

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cervical epidural space wave form analysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cervical epidural injection group

cervical epidural injection group

cervical epidural injection

Intervention Type PROCEDURE

sensitivity, specificity, positive predictive value, negative predictive value

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cervical epidural injection

sensitivity, specificity, positive predictive value, negative predictive value

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cerivical Herniated nucleusus
* Cerivical spinal stenosis
* acute herpes zoster

Exclusion Criteria

* Coagulopathy
* Infectious cervical disease
* Pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ji Hee Hong

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

JiHEE Hong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Keimyung University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-05-037

Identifier Type: -

Identifier Source: org_study_id