COMPARISON OF TWO MONITORS IN DETECTION OF INFANTILE APNEA

两种监测仪检测婴儿呼吸暂停的比较

• 批准号: 6264295
• 负责人: SUSAN F TOWNSEND
• 金额: $ 1.99万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264295
• 关键词: biosensor device; clinical research; diagnosis design /evaluation; diagnosis quality /standard; health services research tag; hospital utilization; human subject; infant human (0-1 year); patient monitoring device; respiratory disorder diagnosis; sleep apnea; telemetry

The IAF ("T Am Fine") 100 infantile apnea monitor is a "non-significant risk device" using a non-impedance repiratory sensor, telemetry and mobile alarm unit (pager) to detect apnea. We hypothesize that the new technology in the IAF100 Monitor will be comparable in the detection of apnea to conventional FDA approved respiratory monitors. The specific aim of this study is to compare the sensitivity and specificity of the IAF 100 infantile apnea monitor to detect true central apnea to a United States legally marketed device, the EdenTec 2000W. Both monitors will be applied to hospitalized infants currently experiencing apnea events, and compared to a reference device, the SensorMedics Repitrace Plus (as the "gold standard" to detect apnea) over a four hour recording period.

IAF（“T Am Fine”）100婴儿呼吸暂停监测器是一种“非显著风险设备”，使用非阻抗呼吸传感器、遥测和移动报警装置（寻呼机）来检测呼吸暂停。我们假设IAF100监测器的新技术在检测呼吸暂停方面可以与FDA批准的传统呼吸监测器相媲美。本研究的具体目的是比较IAF 100婴儿呼吸暂停监测仪检测真中枢呼吸暂停的灵敏度和特异性与美国合法上市的设备EdenTec 2000W。这两款监测仪将应用于目前正在经历呼吸暂停事件的住院婴儿，并与参考设备SensorMedics Repitrace Plus（作为检测呼吸暂停的“黄金标准”）进行比较，记录时间为4小时。