Pre-Operative PSG Assessment of Cardiac Surgery Inpatients
Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE, CLEVELAND, OH, 44103
AbstractDESCRIPTION (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.
* information listed above is at the time of submission.