I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Identification of sensitive electrophysiological index sensible to cerebral ischemic suffering
研究概览
简要总结
During surgery, electrophysiological signals will be acquired with the instrument (ISIS IOM, NeuroExplore, Software Version 4.4, Inomed) already in use at the Neurosurgery Service of the Neurocentro of the Hospital Civic Italian Switzerland in Lugano. Simultaneously to Somatosensorial Evoked Potential (SEP) will also be recorded the Electroencephalography (EEG) activity with the same detection of locations.
For the purposes of the study the signals transmitted to the neurosurgeon through the hardware and the corresponding assessments done by the neurophysiologist responsible for intraoperative monitoring will be recorded. It will also be kept track of procedures performed during surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 old
- •Patient bearer of a not broken cerebral aneurysm, which has been defined per size and morphology susceptible to surgery
- •Aneurysms located on cerebral arteries of the anterior circulation (carotid, middle cerebral arteries, anterior cerebral, anterior communicating, pericallose); Cases of multiple aneurysms are also eligible
- •Informed consent for participation in the study
排除标准
- •Patient with an aneurysm of the posterior circulation (vertebrobasilar system)
- •The aneurysm was a source of bleeding (subarachnoid hemorrhage, intracerebral, intraventricular).
- •Patient with a pace-maker (for the risk that the electric currents used in the study could compromise the operation of the pace-maker)
结局指标
主要结局
Identification of sensitive electrophysiological index sensible to cerebral ischemic suffering
时间窗: up to 3 months
study of the morphology and the analysis of the high frequency of the SEP signal
hardware performance
时间窗: at the moment of the surgery
Collection of information on the hardware performance for reading and interpretation of the SEP and EEG signal and sending an alarm in visual form (light signal) in the eyepiece of the operating microscope during cerebral aneurysm interventions
次要结局
未报告次要终点
研究者
Luca Valci
Dr. med.
Ente Ospedaliero Cantonale, Bellinzona