A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Soft Tissue Injury Following High Energy Extremity Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility and acceptability of the EIT device
研究概览
简要总结
Patients with high-energy extremity trauma will undergo imaging with an EIT device in the Emergency Department, Operating Room, Orthopaedic Clinic, and In-patient hospital rooms. The EIT device is an electrical impedance tomography system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •High energy closed extremity fracture
- •Provision of informed consent
排除标准
- •Metatarsal fractures
- •Injury to both lower extremities precluding contralateral imaging
- •Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
- •Currently pregnant, potentially pregnant, or lactating women
研究组 & 干预措施
Extremity fracture
High energy closed extremity fractures
干预措施: Extremity Surgery (Procedure)
结局指标
主要结局
Feasibility and acceptability of the EIT device
时间窗: 20 minutes
The primary objective of this work is to explore whether changes in impedance measurement associated with EIT are associated with soft tissue injury and readiness for surgical intervention. EIT is a technique which introduces a small amount of electrical current into biologic tissue through an array of electrodes and measures the change in signal to generate images related to the physiology of that tissue.
次要结局
未报告次要终点
研究者
Ida Leah Gitajn
Section Chief, Orthopaedics
Dartmouth-Hitchcock Medical Center