Evaluation of the Compuflo Epidural Instrument for Thoracic Epidural Space Identification
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Pressure Levels in Thoracic Epidural Space
研究概览
简要总结
The purpose of this pilot study is to evaluate whether the Compuflo Epidural Instrument injection pump technology, which is FDA approved for lumbar epidural anesthesia, is also capable of identifying the thoracic epidural space through measurement of pressure levels. While this device is approved by the FDA for use in the procedure of the lumbar epidural, it is not used to perform the epidural procedure but rather to measure the epidural pressure. This study will likewise measure the epidural pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years inclusive
- •BMI 18.5 to 40 inclusive
- •Scheduled for thoracic epidural anesthesia
排除标准
- •Patients younger than 18 years or older than 80 years of age
- •Patients with BMI less than 18.5 or greater than 40
- •Contraindication to thoracic epidural anesthesia
- •Allergy or hypersensitivity to local anesthetics
- •Patients with preexisting nerve damage
- •Patients unable to provide written informed consent
- •Individuals of vulnerable populations: children, pregnant women, prisoners
结局指标
主要结局
Pressure Levels in Thoracic Epidural Space
时间窗: Day 1
The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space
次要结局
- Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique(Day 1)
研究者
Ralf E. Gebhard, MD
Professor of Clinical Anesthesiology
University of Miami