The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- Boston Children's Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- less than 12 months of age
- currently intubated in the ICU
Exclusion Criteria:
- ExSpiron monitor will interfere with a healing surgical procedure site or standard of care
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Infants less than 12 months
intubated infants in ICU
|
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation
大体时间:During 1 hour period in ICU
|
During 1 hour period in ICU
|
|
Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation
大体时间:During 1 hour period in ICU
|
During 1 hour period in ICU
|
|
Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation
大体时间:During 1 hour period in ICU
|
During 1 hour period in ICU
|
合作者和调查者
调查人员
- 首席研究员:Viviane Nasr, MD、Boston Children's Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB-P00023229
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.