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临床试验/NCT02899351
NCT02899351已完成不适用

The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation

研究概览

简要总结

In this research study, the investigators want to learn more about whether the Respiratory Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the number of times per minute a breath is taken (Respiratory Rate), and the amount of air going in and out of the lungs per minute (Minute Ventilation).

It is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected.

The goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.

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
— 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • less than 12 months of age
  • currently intubated in the ICU

排除标准

  • ExSpiron monitor will interfere with a healing surgical procedure site or standard of care

结局指标

主要结局

Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation

时间窗: During 1 hour period in ICU

Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation

时间窗: During 1 hour period in ICU

Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation

时间窗: During 1 hour period in ICU

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Viviane Nasr

Cardiac Anesthesiologist

Boston Children's Hospital

研究点 (1)

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