Confirmation of Tube Placement in Newborns
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of endotracheal tubes correctly placed within the trachea
研究概览
简要总结
Tracheal intubation remains a common procedure in the neonatal intensive care unit (NICU) and the delivery room (DR).
Current guidelines recommend Estimation of correct endotracheal tube (ETT) insertion Our hospital policy recommends to estimate the correct depth (cm) of tube placement by measuring the nasal-ear-tragus length using the "7-8-9 rule" when the endotracheal tube is placed orally. Using this formula an infant weighing 1kg would be intubated to a depth of 7cm, a 2kg infant to a depth of 8cm, and a 3kg infant to a depth of 9cm from the upper lip.
With the new 2015 guidelines, ETT depth is determined by measuring the newborn's nasal septum-tragus length (NTL) and adding 1cm or by using the "initial endotracheal tube insertion depth" table. The NTL is described as the distance from the base of the nasal septum to the tragus of the ear.
However, studies using NTL reported that using this technique only resulted in correct ETT placement in 56% of cases.
Every ETT has markings on the tube, which are called vocal cord markings, which are to be used to provide a guidance to how deep to place the ETT into the trachea. There has been npc study to compare the vocal cord markings with the current approach of NTL.
The current study aims to determine if the use of vocal cord markings during intubation increases percentage of correct endotracheal tube placement compared to NTL in preterm and term infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Months（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/and Neonatal Intensive Care Unit will be eligible.
排除标准
- •Infants will be excluded if their parents refuse to give consent to this study.
结局指标
主要结局
Number of endotracheal tubes correctly placed within the trachea
时间窗: within 30 minutes after endotracheal intubation
次要结局
- Duration of Intubation procedure(0 to 60 seconds)
- Airway injury observed during intubation (including blood, swollen cords, vocal cord redness)(0 to 60 seconds)
- Mortality in the Neonatal Intensive Care Unit(0-200 days)
- Bronchopulmonary Dysplasia at(36 weeks corrected gestational age)
- Changes in Heart rate during intubation procedure(0 to 60 seconds)
- Patent Ductus Arteriosus(0-200 days)
- Necrotizing Enterocolitis(0-200 days)
- Changes in oxygen saturation during intubation procedure(0 to 60 seconds)
- Intraventricular hemorrhage all grades(0-200 days)