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

用于 ICU 镇静持续评估的新型定量监测仪 (OptiSED)

• 批准号: 8592686
• 负责人: TATJANA ZIKOV
• 金额: $ 35.76万
• 依托单位: NEUROWAVE SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-16 至 2017-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8592686
• 关键词: Academic Medical Centers; Address; Adverse effects; Agitation; Algorithms; Anesthesia procedures; Beds; Brain; Caring; Clinical; Clinical Data; Clinical Research; Cost Savings; Critical Care; Critical Illness; Data; Development; Devices; Discrimination; Dose; Electrodes; Electroencephalography; Ensure; Europe; Goals; Healed; Institution; Japan; Lead; Legal patent; Marketing; Measurement; Measures; Medicine; Methodology; Methods; Metric; Monitor; Ohio; Operative Surgical Procedures; Outcome; Patients; Performance; Pharmaceutical Preparations; Phase; Population; Protocols documentation; Recommendation; Resources; Sedation procedure; Signal Transduction; Societies; Staging; State Interests; Subgroup; Surveys; Technology; Time; Training; Validation; Work; base; computerized data processing; cost; healing; improved; instrument; novel; patient population; programs; public health relevance; success; technological innovation; time interval; validation studies

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.

描述（由申请人提供）：我们的总体目标是开发一个新颖的监视器，以确切和连续评估ICU中的镇静剂。这个为期12个月的项目的具体I阶段目标是：1）为ICU患者的镇静状态的持续监测而建立一个客观评分，以及2）对其有效性进行初步评估。该SCOR将集成到Optised Monitor中，这将允许提供患者注重的ICU镇静剂，并满足对重病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，并将与经过广泛验证且广泛使用的里士满搅动镇静量表（RASS）密切一致。开发光学的基本原理是促进更广泛的临床ICU镇静协议的实施，这些方案可显着改善严重患病的预后并降低护理成本。这些方案通过根据患者特定的需求更准确地管理镇静疗法来最大程度地减少控制镇静不良的不利影响。为了实现这一目标，对患者镇静水平的经常重复评估至关重要。目前，有许多临床镇静评分，其中RASS在广泛的ICU患者中表现出了良好的有效性和评估者的可靠性。但是，这些主观分数仅提供零星的患者评估，并需要大幅度增加其频繁给药的资源。而且，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提出了强有力的建议，即使用镇静协议来管理ICU中的镇静剂，但调查数据表明他们的实际用法令人失望地低下。”通过提供自动化的，随时可用的ICU镇静深度测量，可以减轻上述临床镇静评分的局限性。这一阶段将重点介绍基于EEG的ICU镇静分数的开发和初始验证。该12个月计划的很大一部分将致力于在领先的国家临床研究机构进行的临床工作，在该机构中将分两个阶段收集ICU特定的数据，以得出光盘分数并执行其初始验证。为了得出调整分数，我们将适应经过验证和专利的信号处理方法进行实时脑电图分析，这些方法已整合在我们的商业术中脑监测器 - Neurosense（R）中。该阶段项目的具体目的是：（1）对接受镇静的ICU患者进行试点观察性临床研究，并以预定的时间间隔获得连续的EEG信号和临床RASS镇静评分； （2）通过使用（1）中收集的ICU-特定数据调整基于验证的基于小波的脑电图分析来得出基于“客观”的基于EEG的光泽分数，以匹配临床RASS观测值； （3）通过从ICU患者中获取其他临床数据（配对的脑电图和RASS）并使用已知验证方法来验证选择得分。