EpiFaith Syringe for Epidural Space Detection

NCT ID: NCT03983109

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2020-06-01

Brief Summary

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.

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.

Conditions

Epidural Localization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Detection by EpiFaith syringe with air

Fill the EpiFaith Syringe with air for LOR detection

Group Type: EXPERIMENTAL

EpiFaith loss of resistance detect syringe

Intervention Type: DEVICE

An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.

Detection by EpiFaith syringe with saline

Fill the EpiFaith Syringe with saline for LOR detection

Group Type: EXPERIMENTAL

EpiFaith loss of resistance detect syringe

Intervention Type: DEVICE

An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.

Interventions

EpiFaith loss of resistance detect syringe

An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Flat Medical Co., Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien-Kun Ting, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, Please Select, Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EPS01

Identifier Type: -

Identifier Source: org_study_id