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临床试验/NCT02181894
NCT02181894已完成不适用

Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes.

University of Colorado, Denver5 个研究点 分布在 2 个国家目标入组 8 人开始时间: 2014年11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
8
试验地点
5
主要终点
The differences between 4 measurement methods in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.

研究概览

简要总结

Placing artificial airways in infants is often performed under emergent life-saving conditions, which necessitates a procedure that is both accurate and efficient. Intubations of the newborn are often necessary before an accurate weight can be reported and estimations are often inaccurate. The current national standard uses body weight to predict the appropriate tube depth yet this approach tends to place the tube too deep for the smallest and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation, pneumothoraces and death has been suggested to cost $20 to $54 million annually.

The morbidity and the financial impact suggest an optimal and accurate approach to place ETT in neonates has not been identified. Other methods to estimate the proper depth of the orotracheal tube have shown promise yet no comparison studies have been performed. Identifying the most accurate method to safely place neonatal orotracheal tubes will improve placement precision and reduce adverse events and their associated costs.

Hypothesis

Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to tragus length will become the most accurate method for predicting the safe depth of orally placed neonatal endotracheal tubes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Minute 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Infants orally intubated and admitted into the Neonatal Intensive Care Unit.

排除标准

  • Previous intubation
  • Hydrops fetalis
  • Thoracic congenital anomalies
  • Facial abnormalities
  • Naso-tracheal intubation

结局指标

主要结局

The differences between 4 measurement methods in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.

时间窗: Up to 3 years

次要结局

  • The differences in head position in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.(Up to 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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