Pre-Operative PSG Assessment of Cardiac Surgery Inpatients

心脏手术住院患者的术前 PSG 评估

• 批准号: 7157535
• 负责人: Hani Akram Kayyali
• 金额: $ 98.09万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7157535
• 关键词: clinical research; hospitals; sleep; surgery

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.

描述（由申请人提供）：手术患者的围手术期治疗可能会因睡眠不足的呼吸（SDB）而严重复杂。麻醉药可以抑制中枢神经系统（CNS），减少咽肌肉张力并抑制呼吸驱动，从而促进SDB患者的气道闭塞。美国麻醉师学会以草稿形式散发的许多研究，包括促进对SDB患者的仔细管理，包括术前睡眠评估。尽管具有重要意义，但睡眠障碍诊断尚未在手术前进行。虽然可以在实验室进行测试，但最好在住院室进行睡眠评估，因为它对他们来说更舒适，并且不会中断计划的心脏护理。其他原因包括在大量医院中缺乏睡眠设施，日程安排和费用（将在此提案中进行评估）。 该提案将完成新型遥测睡眠监视器（Crystal 20-H）的开发，该睡眠监护仪将允许在任何时候出现在任何病房中。该系统基于以前的SBIR II阶段技术，其小型且无线为专门为该应用程序设计的软件和硬件。它将将PSG数据从患者的房间传输到护士车站，并将其带到睡眠实验室（如果有的话）。我们将通过对克利夫兰诊所基金会和约翰·霍普金斯大学（Johns Hopkins University）的400名心血管手术患者进行大量前瞻性评估来证明设备的安全性和功效，我们认为这从未做过。重要的研究结果包括证明比当前方法（睡眠评估问卷）表现出色，并量化该人群中的SDB患病率和发病率。在这种情况下，睡眠评估的成本效益将确定。我们还将获得FDA批准。除了在此应用中证明设备有效性外，该提案的有力结果还将提高对这种新兴未满足的临床需求的认识水平，并鼓励医院纳入其治疗前协议中的住院PSG评估，以评估AT风险患者。