Identify the Epidural Space With EpiFaith Syringe in Air and Saline Based Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Success of Epidural Localization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 years and older
- •Surgery requiring epidural anesthesia or analgesia
- •ASA Physical Status 1 to 3
排除标准
- •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
结局指标
主要结局
Success of Epidural Localization
时间窗: 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.
次要结局
- Duration of the Epidural Space Localization Procedure(30 minutes)
- The Distance From the Skin to the Epidural Space(30 minutes)
- Number of Change Insertion Segment(30 minutes)
- The Time to Identify the Epidural Space(30 minutes)
- Number of Attempts(30 minutes)
- Number of the Occurrence of False Positive(30 minutes)