Comparison of NeuroSense/NeuroWave and Sedline/Masimo Indices for Measuring Depth of Sedation in the Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparison of the depth of sedation indices per assigned RASS score using the prediction probability
研究概览
简要总结
In the intensive care unit of the Free University hospital of Brussels, sedated patients are standardly monitored with the Masimo SEDline device to see how deeply a patient is asleep. During this study we want to attach 1 extra device to 30 sedated patients, lying in the intensive care unit. This device, called the NeuroSENSE brain monitor from Neurowave systems, uses a different scale to indicate the ideal depth of sedation. In total, both devices will be hung on a patient for 2 times 35 minutes. At minute 33, a RASS score will be determined in each patient. This score will be determined by talking to the patient or administering a pain stimulus. Based on the reaction of the patient an estimation can be made how deeply a patient is sleeping. Our goal is to find out which device correlates best with the effective clinical state of the patient.
详细描述
Adequate sedation level is important for patient comfort and safety. As under- and oversedation are common several devices are used that measure the Depth of Anesthesia (DoA). Each device uses its proprietary algorithm to calculate a depth of anesthesia index and each index has its own optimal range. The optimal range for the NeuroSense monitor (NeuroWave Systems inc., Cleveland, OH, USA) is between 40 and 60, while the optimal range for the SEDline monitor (Masimo Corporation; Irvine, CA, USA) is between 25 and 50. When the device indicates a value within these limits, the patient is optimally anesthetized for a surgical procedure. In this study, 30 patients will be monitored simultaneously by both the Neurowave and SedLine devices. The study will determine which device is the most accurate and therefore the most ideal for use in the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Sedated patients hospitalized in ICU of the University Hospital of Brussels
- •Patients who are monitored with the SEDline/Masimo monitor
- •Patients who receive Remifentanil at a maximum concentration of 0,2 μg/kg/min and propofol with a concentration between 0,5-4,0 mg/kg/h
- •Age above 18 years
排除标准
- •Patients with facial trauma
- •Pregnant patients
- •Patients who received muscle re-laxants
- •Patients in prone position
- •Lack of informed consent from the family
- •Patients who are hemodynamically unstable
- •Patients with neurotrauma or every other neurologic disorder
- •Patients post neurosurgery
结局指标
主要结局
Comparison of the depth of sedation indices per assigned RASS score using the prediction probability
时间窗: 33 minutes
The main objective of the study is to compare the DoA indices of the NeuroSense/NeuroWave monitor and the SEDline/Masimo monitor in sedated patients in ICU. Both values are then correlated with the patient's clinical sedation level by assigning a RASS score to the patient each time. The RASS score stands for Richmond Agitation Sedation Scale and ranges from -5 to +4. A score of -5 stands for a patient who is unresponsive to any stimuli whereas a score of +4 means a highly combative patient. To determine which device correlates best with the clinic, predictive probability will be used. The prediction probability is a value between 0 and 1. A score of 1 corresponds to a correct classification of the DoA in each case. A value of 0 corresponds to a discordance between the clinic and the index value. The device whose predictive probability is closest to 1 correlates best with the clinic and will likely be the best device to use.
次要结局
未报告次要终点