New Quantitative Monitor for Continuous Assessment of ICU Sedation (OptiSED)

描述（由申请人提供）：我们的总体目标是开发一种新型监测仪OptiSED，用于ICU中镇静的精确和连续评估。这个为期12个月的项目的具体I期目标是：1）开发一个客观评分，用于连续监测ICU患者的镇静状态，2）对其有效性进行初步评估。该评分将集成到OptiSED监护仪中，这将允许提供患者定制的ICU镇静，并解决危重病患者有效镇静管理的未满足需求。OptiSED ICU镇静评分将基于EEG信号的高级信号处理，并与广泛验证和广泛使用的里士满躁动镇静量表（RASS）非常一致。开发OptiSED的基本原理是促进临床ICU镇静协议的更广泛实施，该协议已被证明可显著改善危重病患者的结局并降低护理成本。这些方案旨在更准确地根据患者的具体需求给予镇静治疗，从而最大限度地减少镇静控制不良的不良影响。为了实现这一目标，经常重复评估病人的镇静水平是必不可少的。目前，临床镇静评分有多种，其中RASS在ICU患者中表现出良好的效度和评分者间信度。然而，这些主观评分仅提供零星的患者评估，并且需要显著增加用于其频繁施用的资源。此外，它们不能应用于ICU患者的某些亚组。因此，“尽管重症监护医学会强烈建议使用镇静协议来管理ICU中的镇静，但调查数据表明，它们的实际使用率低得令人不安”。OptiSED将通过提供自动化、易于获得的ICU镇静深度测量来缓解临床镇静评分的上述局限性。本阶段I将重点关注基于EEG的OptiSED评分用于ICU镇静的开发和初步验证。这个为期12个月的项目的很大一部分将致力于在一家领先的国家临床研究机构进行的临床工作，在那里将分两个阶段收集ICU特定数据，以得出OptiSED评分并进行初步验证。为了获得OptiSED评分，我们将采用经过验证的专利信号处理方法进行实时EEG分析，这些方法集成在我们的商业术中脑监测仪- NeuroSENSE（R）中。该I期项目的具体目标是：（1）在经历镇静的ICU患者中进行试点观察性临床研究，并以预定义的时间间隔获取连续EEG信号和临床RASS镇静评分;（2）通过使用（1）中收集的ICU特定数据调整我们经过验证的基于小波的EEG分析，推导出“客观”基于EEG的OptiSED评分，以匹配临床RASS观察结果;（3）通过从ICU患者获取额外的临床数据（成对的EEG和RASS）并使用临床仪器的已知验证方法来初步验证OptiSED评分。

DESCRIPTION (provided by applicant): Our overall objective is to develop a novel monitor, OptiSED, for the precise and continuous assessment of sedation in the ICU. The specific Phase I goals of this 12-month project are to: 1) develop an objective score for continuous monitoring of sedation status in ICU patients, and 2) perform an initial assessment of its validity. This scor will be integrated in the OptiSED monitor, which will allow delivery of patient-customized ICU sedation and address the unmet need for an effective sedation management in critically ill. The OptiSED ICU sedation score will be based on the advanced signal processing of EEG signals and will closely agree with the extensively validated and widely-used Richmond Agitation Sedation Scale (RASS). The rationale for developing OptiSED is to facilitate wider implementation of clinical ICU sedation protocols shown to significantly improve outcomes in critically ill and reduce care costs. These protocols minimize the adverse effects of poorly controlled sedation by aiming to administer the sedation therapy more accurately and according to patient-specific needs. To achieve this goal, frequently repeated assessments of the patient's level of sedation are essential. Currently, there are a number of clinical sedation scores, among which the RASS has shown excellent validity and inter-rater reliability in broad range of ICU patients. However, these subjective scores provide only sporadic patient assessments and require significant increase in resources for their frequent administration. Also, they cannot be applied to certain subgroups of ICU patients. Thus, "despite strong recommendations by the Society of Critical Care Medicine that sedation protocols be used to manage sedation in the ICU, survey data suggest their actual usage has been disappointingly low". The OptiSED would alleviate the above limitations of clinical sedation scores by providing an automated, readily available measurement of ICU sedation depth. This Phase I will focus on the development and initial validation of the EEG-based OptiSED score for ICU sedation. Significant portion of this 12-month program will be dedicated to clinical work to be performed at a leading national clinical research institution, where ICU-specific data will be collected in two stages to derive the OptiSED score and perform its initial validation. To derive the OptiSED score, we will adapt our proven and patented signal processing methods for real-time EEG analysis, which are integrated in our commercial intraoperative brain monitor - NeuroSENSE(R). The specific aims of this Phase I project are: (1) To carry out a pilot observational clinical study in ICU patients undergoing sedation and acquire continuous EEG signals and clinical RASS sedation scores at predefined time intervals; (2) To derive the "objective" EEG-based OptiSED score to match the clinical RASS observations by adapting our proven wavelet-based EEG analysis using ICU- specific data collected in (1); (3) To preliminary validate the OptiSED score by acquiring additional clinical data (paired EEGs and RASS) from ICU patients and using known validation methods for clinical instruments.