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COMPARISON OF TWO MONITORS IN DETECTION OF INFANTILE APNEA

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
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30

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中文摘要
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英文摘要
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.
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  • 批准号:
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  • 项目类别:
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  • 财政年份:
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  • 负责人:
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  • 依托单位:
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