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临床试验/NCT03770104
NCT03770104Unknown不适用

Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room According to Two Different Methods Based on Estimated Birth Weight. Randomized Clinical Trial (NeoTEDI)

Tania Carbayo Jiménez2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
280
试验地点
2
主要终点
Frequency of correct endotracheal tube (ETT) position

研究概览

简要总结

The investigators wished to determine whether estimating endotracheal tube (ETT) insertion depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather than the depth using the formula given by international guidelines recommendations (6 plus weight) resulted in more correctly positioned endotracheal tube tips in newborns intubated in the delivery room.

详细描述

A number of different methods have been used to guide clinicians in estimating the correct depth of insertion of endotracheal tube (ETT) at the time of oral intubation. Minor differences in tube length may lead to intubation of the right main bronchus or extubation. However, none of them has shown to be better than others when compared in the context of randomized clinical trials.

Commonly, clinicians use a formula based on the newborn's weight (Tochen formula: ETT insertion depth (cm)=6 + wt (kg)). While this method is widely used and recommended by international guidelines, it has been found to frequently result in incorrectly positioned tubes, especially in infants <1000 g in weight in whom it may lead to overestimation of ETT insertion depth.

On the other hand, Spanish Society of Neonatology recommended in their last published guidelines (2017) to use an alternative version formula (ETT insertion depth (cm)=5.5 + wt (kg)), which is commonly used among Spanish neonatal units.

Finally, no studies have been performed in newborns who require oral intubation in the delivery room, since these intubations are usually excluded because infants are not routinely weighed prior to resuscitation and weight can not be rapidly obtained. Given that Obstetric Unit in our hospital is a high standard one with a highly reliable estimated fetal weight in prenatal ultrasound, the investigators will use estimated fetal weight referred on ultrasounds or 50th percentile for gestational age for calculations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Clinicians and neonatal nurses will not masked to group assignment. However, Neonatal Intensive Care Unit nurses who take care of the patient will be mask, as well as both pediatric radiologist who will determine the main outcome of the study.

入排标准

年龄范围
— 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • All newborns requiring endotracheal oral intubation in the delivery room after birth.
  • Parents accept deferred informed consent to participate in the study.

排除标准

  • Prior to randomization
  • Uncontrolled gestation where both estimated fetal weight and gestational age are unknown.
  • Upper airway anomaly or a lung anomaly that would distort the upper airway anatomy.
  • Infants who require nasotracheal intubation
  • Infants who are intubated in the Neonatal Intensive Care Unit
  • Post-randomization
  • Newborns who are randomized but finally do not require intubation
  • Intubated newborns who are electively extubated in the delivery room
  • Parents / legal guardian refuse to give consent to participate in the study

结局指标

主要结局

Frequency of correct endotracheal tube (ETT) position

时间窗: 1 hour

Correct ETT position, that is, tip between the upper border of the first thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on a chest X-ray as determined by one pediatric radiologist masked to group assignment.

次要结局

  • Number of intubation attempts in the delivery room(2 days)
  • Number of accidental extubations prior to chest X-ray(2 days)
  • Professional healthcare sensation about correct or incorrect ETT position(1 day)
  • Frequency of ETT repositioning prior and after chest X-ray(2 days)
  • Frequency of incorrect ETT position(2 days)
  • Oxygen therapy at 28 days(1 month)
  • Oxygen therapy at 36 weeks postmenstrual age(3 months)
  • Frequency of complications secondary to incorrect ETT position(7 days)
  • Duration of ventilation(3 months)

研究者

发起方
Tania Carbayo Jiménez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tania Carbayo Jiménez

Tania Carbayo Jimenez, MD

Hospital Universitario 12 de Octubre

研究点 (2)

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