BI-SENSES: Validation of Nasal Versus Frontal Placement of the SedLine® Sensor Through Processed Electroencephalography in Adult Patients Undergoing General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Validation of nasal SedLine® EEG sensor position for monitoring the depth of anesthesia using processed electroencephalograph values
研究概览
简要总结
SedLine® Brain Function Monitoring provides real-time insight into a patient's depth of anesthesia with bilateral data acquisition and processing of electroencephalogram (EEG) signals. Four active EEG leads collect data from the frontal lobe with a sensor position on the patient's forehead.
Whenever a frontal approach for neurosurgical procedures is required or the frontal placement of the EEG is not indicated, it would not be possible to place the SedLine® .
Numerous studies have analyzed the change of position and the application of alternative positions for other devices used in assessing the depth of anesthesia. Albeit, yet to date, there is no study that analyzed the application of alternative positions for the SedLine® sensor.
详细描述
The purpose of study is to compare the standard forehead placement versus a nasal placement of SedLine® sensor for neuromonitoring.
The hypothesis is that placing the central sensors in the montage approximately 2 cm below the standard recommended placement, across the nasal bridge and then running under the eyes to the normal temporal leads placement would put the entire montage out of the operative field and would still have corresponding values and EEG signals.
The primary outcome measure is to monitor and compare processed electroencephalograph (EEG) values (PSi- Patient State Index, SEFL- Spectral Edge Frequency Left, SEFR- Spectral Edge Frequency Right, SR-Suppression Ratio, EMG-Electromyography, ARTF-Artifact) and EEG waveforms, on both sensors (standard-Forehead and alternative-Nasal)
Other parameters that will be measure are patient demographics (age, sex, surgery, ASA status, weight, height, BMI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients older than 18 years of age, both genders.
- •Patients undergoing simple or complex surgery.
- •American Society of Anesthesiologists Classification (ASA) score I to III.
排除标准
- •American Society of Anesthesiologists Classification (ASA) score IV and V.
- •Emergency cases
- •Cognitive/Mentally impaired or unable to provide consent
- •Previous neurological problems affecting EEG
- •Use of sedative or drugs that can alter EEG readings
- •Patients under head and neck surgery
结局指标
主要结局
Validation of nasal SedLine® EEG sensor position for monitoring the depth of anesthesia using processed electroencephalograph values
时间窗: One year
Determine whether it is possible to apply an alternative SedLine® EEG sensor position in a situation where a standard-forehead position is not possible.
次要结局
未报告次要终点
研究者
Boris Tufegdzic
Asst Prof Dr Boris Tufegdzic
Cleveland Clinic Abu Dhabi