Clinical trial NCT03983109: EpiFaith Syringe for Epidural Space Detection
Official title: Identify the Epidural Space With EpiFaith Syringe in Air and Saline Based Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Localization
Keywords: EpiFaith
Epidural localization
Lead sponsor: Flat Medical Co., Ltd
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Success of Epidural Localization
timeFrame: 30 minutes
Secondary outcomes:
measure: The Time to Identify the Epidural Space
timeFrame: 30 minutes
measure: Duration of the Epidural Space Localization Procedure
timeFrame: 30 minutes
measure: Number of Attempts
timeFrame: 30 minutes
measure: The Distance From the Skin to the Epidural Space
timeFrame: 30 minutes
measure: Number of Change Insertion Segment
timeFrame: 30 minutes
measure: Number of the Occurrence of False Positive
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Please Select
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chien-Kun Ting, MD
role: PRINCIPAL_INVESTIGATOR
References: