EpiFaith Syringe for Epidural Space Detection

June 10, 2019 updated by: Flat Medical Co., Ltd

Identify the Epidural Space With EpiFaith Syringe in Air and Saline Based Procedures

The objective of the study is to verify the efficacies of both air and saline based procedure of EpiFaith syringe for assisting the needle localization of the epidural space.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Please Select
      • Taipei, Please Select, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20 years and older
  • Surgery requiring epidural anesthesia or analgesia
  • ASA Physical Status 1 to 3

Exclusion Criteria:

  • Bleeding and clotting disorders

    • Platelet count < 100,000 / mm3
    • International normalized ratio (INR) > 1.5
  • History of peripheral neuropathy
  • Neuromuscular or neuropsychiatric disease
  • Marked spinal deformities or a history of spinal instrumentation
  • Systemic infection
  • Skin infection at the injection site
  • Significant heart failure, e.g. New York Heart Association (NYHA) Functional Classification 3 or 4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Detection by EpiFaith syringe with air
Device: EpiFaith loss of resistance detect syringe
An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.
Experimental: Detection by EpiFaith syringe with saline
Device: EpiFaith loss of resistance detect syringe
An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of epidural localization
Time Frame: 30 minutes
Defined as the catheter can be inserted into epidural space successfully, no cold perception in the blocked dermatomes after the injection of anesthetic by cold sensation test, and no occurrence of inadvertent dural puncture.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to identify the epidural space
Time Frame: 30 minutes
Defined as the time of the successful localization from the first syringe attached to the Tuohy needle to the occurrence of LOR signal.
30 minutes
Duration of the epidural space localization procedure
Time Frame: 30 minutes
Defined as the time from the puncture of skin to the successful insertion of the epidural catheter.
30 minutes
Number of attempts
Time Frame: 30 minutes
Defined as the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test.
30 minutes
The distance from the skin to the epidural space
Time Frame: 30 minutes
30 minutes
Number of change insertion segment
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Flat Medical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 10, 2019

First Posted (Actual)

June 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 10, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EPS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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