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临床试验/NCT07704320
NCT07704320招募中不适用

Pilot Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes in Infants at Risk for Apnea

William Marsh Rice University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Accuracy of BreathAlert

研究概览

简要总结

A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BreathAlert, a low cost battery-powered monitor that detects and corrects apnea. This study evaluates the ability of BreathAlert to detect respiration and apneic episodes in infants. Data from BreathAlert and vital signs monitors is collected. The performance of BreathAlert in respiration and apnea detection is compared with traditional vital sign monitoring which may include temperature, heart rate, EKG, respiratory rate, SPO2 and impedance pneumography.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants will be identified using the eligibility criteria stipulated below.
  • The patient is currently being treated at QECH in the neonatal or pediatric ward.
  • The patient is deemed to be at risk for apnea or in need of respiratory rate monitoring.
  • A BreathAlert device is available for use while the patient is at risk for apnea.
  • The patient's caregiver has provided informed consent for their child to participate.

排除标准

  • 未提供

结局指标

主要结局

Accuracy of BreathAlert

时间窗: Maximum of one week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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