EpiFaith Syringe for Epidural Space Detection

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: Completed
• Conditions: Epidural Localization
• Intervention / Treatment: Device: EpiFaith loss of resistance detect syringe

Detailed Description

This is a single blind, randomized study. Subjects who will receive a surgery requiring epidural anesthesia or analgesia and meet all of the study criteria will be enrolled in the study. All subjects must sign an informed consent and receive a copy of the signed and dated informed consent form prior to participation in the trial.

The study consists of 2 study visits: Visit 1 (Screening Visit) and Visit 2 (Operative Visit). After screening, eligible subject will be randomly assigned to one of the following groups: Group A: detection by EpiFaith syringe with air; Group S: detection by EpiFaith syringe with saline with a 1:1 ratio. In Visit 2, the following variables will be recorded and rated during the process of epidural space localization: Success of epidural localization, time to identify the epidural space, duration of the epidural space localization procedure, number of attempts, Number of the occurrence of false positive, the distance from the skin to the epidural space, and number of change insertion segment. Adverse events and concomitant treatments will be also recorded.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Please Select
    • Taipei, Please Select, Taiwan, 11217
      • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Detection by EpiFaith syringe with air; Fill the EpiFaith Syringe with air for LOR detection	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; Fill the EpiFaith Syringe with saline for LOR detection	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	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	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	Defined as the time from the puncture of skin to the successful insertion of the epidural catheter.	30 minutes
Number of Attempts	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	Defined as the insertion distance of the needle after locating the epidural space.	30 minutes
Number of Change Insertion Segment	Number of change insertion segment during the epidural localization procedure.	30 minutes
Number of the Occurrence of False Positive	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

Collaborators and Investigators

• Sponsor: Flat Medical Co., Ltd
• Investigators: Principal Investigator: Chien-Kun Ting, MD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

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): July 5, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: EpiFaith; Epidural localization
• Other Study ID Numbers: EPS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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