Pre-Operative PSG Assessment of Cardiac Surgery Inpatients

描述（由申请人提供）：睡眠呼吸障碍（SDB）可能会严重影响手术患者的围手术期管理。麻醉药可抑制中枢神经系统（CNS），降低咽肌张力，抑制呼吸驱动，促进SDB患者气道阻塞。包括美国麻醉医师协会以草案形式分发的新指南在内的大量研究正在促进对SDB患者的仔细管理，包括术前睡眠评估。尽管意义重大，但睡眠障碍的诊断并不是在手术前完成的。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进行，因为这对他们来说更舒适，并且不会中断计划的心脏护理。其他原因包括大量医院缺乏睡眠设施、时间安排和成本（将在本提案中进行评估）。 该提案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）。该系统基于之前的SBIR Phase II技术，体积小，无线，软件和硬件专为该应用设计;它将把PSG数据从病人的房间传输到护士站和睡眠实验室（如果有的话）。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术前大型前瞻性评价来证明器械的安全性和有效性，我们认为这是以前从未做过的。重要的研究结果包括证明优于当前方法（睡眠评估问卷）的上级性能，并量化该人群中SDB的患病率和发病率。将确定在这种情况下睡眠评估的成本效益。我们还将获得FDA的批准。除了证明该应用中的器械有效性外，该提案的有力结果将提高对这一新兴未满足临床需求的认识水平，并将鼓励医院在其术前方案中纳入对风险患者的住院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.