A New Pressure Guided Mechatronic Tool for Epidural Space Detection: Feasibility Assessment in a Clinical Scenario
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Loss of resistance detection
研究概览
简要总结
This study sought to perform the feasibility assessment of a new, non-invasive device for Loss of Resistance (LOR) detection in clinical settings. The device in charge is a mechatronic device optimized in its configurations in order to detect Loss of Resistance while performing epidural injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients whose pathology requires specific treatment such as epidural infiltration
排除标准
- •coagulation abnormalities or assumption of anticoagulant drugs
研究组 & 干预措施
Procedures with the use of device for LOR monitoring
Patients enrolled suffered from chronic back pain and underwent epidural infiltration. The device is used.
干预措施: LOR measurement via device (Device)
Procedures without the use of device for LOR monitoring
Patients enrolled suffered from chronic back pain and underwent epidural infiltration
结局指标
主要结局
Loss of resistance detection
时间窗: throughout the epidural infiltration procedure
A non invasive device to detect loss of resistance during epidural infiltration
次要结局
未报告次要终点
研究者
Massimiliano Carassiti
Associate Professor
Campus Bio-Medico University