Pre-Operative PSG Assessment of Cardiac Surgery Inpatients

描述(由申请人提供)：手术患者的围手术期管理可能会因睡眠障碍呼吸(SDB)而严重复杂化。麻醉药可以抑制中枢神经系统(CNS)，降低咽肌张力，抑制呼吸动力，从而促进SDB患者的呼吸道闭塞。许多研究，包括美国麻醉学家协会以草案形式分发的新指南，都在促进对SDB患者的谨慎管理，包括术前睡眠评估。尽管睡眠障碍的诊断很重要，但在手术前不会进行诊断。虽然测试可以在实验室进行，但住院患者的睡眠评估最好在他们的病房里进行，因为这样对他们来说更舒服，而且不会扰乱计划中的心脏护理。其他原因包括大量医院缺乏睡眠设施、日程安排和成本(将在本提案中进行评估)。 这项提议将完成一种新型遥测睡眠监测器(Crystal 20-H)的开发，该监测器将允许在任何医院房间随时进行有人值守的多导睡眠图(PSG)。该系统基于以前的SBIR二期技术，体积小，无线，配有专门为此应用设计的软件和硬件；它将PSG数据从患者的房间传输到护士站和多层楼外的睡眠实验室(如果有)。我们将通过在克利夫兰临床基金会和约翰·霍普金斯大学对400名心血管手术患者进行大型前瞻性评估来证明设备的安全性和有效性，我们认为这是以前从未做过的。重要的研究成果包括显示出优于当前方法的表现(睡眠评估问卷)，并量化了SDB在该人群中的患病率和发病率。将确定在该环境中进行睡眠评估的成本效益。我们还将获得FDA的批准。除了在这一应用中展示设备的有效性外，这项提案的强大结果还将提高人们对这一新出现的未得到满足的临床需求的认识水平，并将鼓励医院在其手术前方案中包括针对高危患者的住院PSG评估。

DESCRIPTION (provided by applicant): The perioperative management of surgery patients can be seriously complicated by Sleep Disordered Breathing (SDB). Anesthetics can suppress the Central Nervous System (CNS), reduce pharyngeal muscle tone and depress respiratory drive, which promote airway occlusion in SDB patients. Numerous research including a new guideline circulated in draft form by the American Society of Anesthesiologists is promoting careful management of SDB patients including preoperative sleep evaluation. Despite its significance, sleep disorders diagnosis is not done before surgeries. While testing can be done in the lab, sleep evaluation of hospitalized patients is best done in their hospital room because it is more comfortable to them and does not interrupt planned cardiac care. Other reasons include lack of sleep facilities in a significant number of hospitals, scheduling and cost (will be evaluated in this proposal). This proposal will complete the development of a novel telemetry sleep monitor (Crystal 20-H) that will allow attended polysomnography (PSG) to occur in any hospital room at any time. The system, based on previous SBIR Phase II technology, is small and wireless with software and hardware specifically designed for this application; it will transmit PSG data from the patient's room to a nurse's station and to a sleep lab (if available) many floors away. We will demonstrate device safety and efficacy by conducting a large prospective evaluation on 400 cardiovascular surgery patients pre-operatively at the Cleveland Clinic Foundation and Johns Hopkins University, which we believe has never been done previously. Important study outcomes include demonstrating superior performance over current methods (sleep assessment questionnaires), and quantifying SDB prevalence and morbidity in that population. Cost effectiveness of sleep evaluation in that setting will be determined. We will also obtain FDA approval. In addition to demonstrating device effectiveness in this application, the powerful results from this proposal will raise the awareness level for this emerging unmet clinical need and will encourage hospitals to include in their pre-surgical protocols inpatient PSG assessment for at risk patients.