COMPARISON OF TWO MONITORS IN DETECTION OF INFANTILE APNEA

IAF(“T am Fine”)100婴儿呼吸暂停监测仪是一种“非重大危险设备”，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监护仪中的新技术在检测呼吸暂停方面将与FDA批准的传统呼吸监护仪相媲美。这项研究的具体目的是比较IAF 100婴儿呼吸暂停监测仪与美国合法销售的EdenTec 2000W设备检测真正中枢性呼吸暂停的敏感性和特异性。这两种监护仪都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 Repetrace Plus(作为检测呼吸暂停的“黄金标准”)在四个小时的记录期内进行比较。

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.