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中精确和持续的镇静评估。这个为期12个月的项目的具体I期目标是：1)为ICU患者镇静状态的持续监测制定客观评分，2)对其有效性进行初步评估。该评分将集成到OptiSED监测器中，这将允许提供患者定制的ICU镇静，并解决危重患者有效镇静管理的未满足需求。OptiSED ICU镇静评分将基于脑电图信号的高级信号处理，并将与广泛验证和广泛使用的Richmond躁动镇静量表（RASS）密切一致。开发OptiSED的基本原理是促进临床ICU镇静方案的更广泛实施，该方案可显着改善危重患者的预后并降低护理成本。这些方案旨在根据患者的具体需要更准确地实施镇静治疗，从而最大限度地减少控制不佳的镇静的不良影响。为了实现这一目标，经常反复评估患者的镇静水平是必不可少的。目前，临床有许多镇静评分，其中RASS在广泛的ICU患者中表现出优异的效度和评分间信度。然而，这些主观评分仅提供零星的患者评估，并且需要大量增加资源以进行频繁的管理。此外，它们不能应用于ICU患者的某些亚组。因此，“尽管重症监护医学协会强烈建议在ICU中使用镇静方案来管理镇静，但调查数据表明，它们的实际使用率低得令人失望”。OptiSED通过提供一种自动化的、易于获得的ICU镇静深度测量方法，减轻了上述临床镇静评分的局限性。第一阶段将重点研究基于脑电图的ICU镇静评分的开发和初步验证。这个为期12个月的项目的重要部分将在一家领先的国家临床研究机构进行临床工作，其中icu特定数据将分两个阶段收集，以得出OptiSED评分并进行初步验证。为了获得OptiSED评分，我们将采用我们成熟的专利信号处理方法进行实时脑电图分析，这些方法集成在我们的商业术中脑监测器NeuroSENSE(R)中。本一期项目的具体目的是：(1)在ICU镇静患者中开展试点观察性临床研究，以预先设定的时间间隔获取连续脑电图信号和临床RASS镇静评分；(2)根据(1)中收集的ICU特定数据，采用我们已证实的基于小波的EEG分析，得出“客观的”基于EEG的OptiSED评分，以匹配临床RASS观察结果；(3)通过获取ICU患者的额外临床数据（配对脑电图和RASS），并使用已知的临床仪器验证方法，对OptiSED评分进行初步验证。

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.