Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data
研究概览
简要总结
Intraspinal pressure monitoring has been advanced as a potential technique for evaluating spinal cord perfusion after traumatic spinal cord injury. In this study, the investigators aim to validate the technique for insertion of a fiberoptic pressure monitoring device in the subarachnoid space at the site of injury for measurement of intraspinal pressure and spinal cord perfusion pressure. The primary objective of this study is to validate the methodology of invasive intraspinal pressure monitoring to derive parameters for optimal spinal cord perfusion pressure, spinal cord reserve capacity and spinal reactivity index using data obtained during the patient's stay in the intensive care unit.
Secondary objectives of this study will be to a) evaluate the safety of invasive intraspinal pressure monitoring, b) prospectively evaluate the overall relationship between spinal cord perfusion pressure and functional outcomes in patients with acute traumatic spinal cord injury and c) evaluate the relationship between spinal cord perfusion pressure, motor evoked potentials and functional outcomes after incomplete spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• patients with acute traumatic spinal cord injury ASIA A, B or C
- •age between 18-70yrs
排除标准
- •patients with central cord syndrome
- •patients presenting to hospital >48hrs from time of spinal cord injury
- •patients unable to communicate in english language
- •pre-existing cognitive impairment
- •penetrating spinal cord injury
- •pre-existing neurodegenerative disorder involving brain or spinal cord
- •patients with concomitant injuries requiring emergent surgical intervention
结局指标
主要结局
Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data
时间窗: 1 year
Derivation of parameters for optimal spinal cord perfusion pressure.
次要结局
- Measurement of the accuracy of probe placement in relation to the site of injury(1 year)
- Measure the correlation between spinal cord perfusion pressure and the American Spinal Injury Association (ASIA) Impairment scale, Quality of Life Index and Spinal Cord Independence Measure score.(1 year)
- Record rates of adverse events in patients having insertion of intraspinal pressure monitor(1 year)
研究者
Perry Dhaliwal
Assistant Professor of Neurosurgery
University of Manitoba