跳至主要内容
临床试验/NCT01870622
NCT01870622已完成不适用

Confirmation of Correct Tracheal Tube Placement in Newborn Infants - a Randomized Control Trial

University of Alberta2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年6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
100
试验地点
2
主要终点
Using flow waves will increase the percentage of correct tube placement in newborn infants

研究概览

简要总结

Most premature babies have difficulty breathing at birth and need help (resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. To gently inflate an infant's lungs the clinical team places a breathing tube in the windpipe and blow air into your baby's lung (puffs). With the first puffs the clinical team checks if the breathing tube is correctly placed within the windpipe. The investigators routinely use a detector which checks for exhaled carbon dioxide or the graphical display of waves forms of the infants breathing to check that the breathing tube position. However, the investigators do not know which one (exhaled carbon dioxide or the graphical display of waves forms) is better to check that the breathing tube position is correct and therefore the investigators would like to study them. The purpose of this study is to compare exhaled carbon dioxide detectors (ECO2 group) with the graphical display of waves forms (flow waves group) to provide us with information on how the investigators can help babies who struggle with breathing at birth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 120 Days(Child)
性别
All
接受健康志愿者

入选标准

  • All infants (term and preterm) born at The Royal Alexandra Hospital who require endotracheal intubation in the delivery room or neonatal intensive care unit will be recorded.

排除标准

  • Infants will also be excluded if their parents refuse to give consent to this study.

结局指标

主要结局

Using flow waves will increase the percentage of correct tube placement in newborn infants

时间窗: within the first 10 inflations

Flow waves and exhaled Carbon dioxide will be compared using the numbers of inflation needed to identify correct tube placement. We will compare the number of inflation in each group to identify which device can identify correct tube placement faster and more accurately. Outcome will be number of inflation until correct tube placement has been identified.

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 (2)

Loading locations...

相似试验