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