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临床试验/NCT02822846
NCT02822846已完成不适用

Evaluation of Diagnostic Qualities of Lung Ultrasonography to Monitor the Position of the Intubation Probe

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2016年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
1
主要终点
Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography

研究概览

简要总结

The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to monitor the position of the intubation probe.

The primary assessment criterion is of study the position of the intubation probe with two examinations carried out independently :

  • sonography
  • chest radiography

A correct position of the intubation probe will be considered if there is :

  • Highlighting of the extremity of the intubation probe in endo tracheal
  • Highlighting bilateral lung sliding

详细描述

Oesophageal intubation can cause death. Selective intubation can induce a poor ventilation, hypoxemia, atelectasis etc… It's not rare in paediatric intubation. The prevalence of malposition of endotracheal tube is 30 to 40% in babies and infants less than 1 year old. Currently doctors try to detect malposition of intra-tracheal tube by auscultation and capnograms and chest radiography is needed to confirm it. The Chest X ray is the gold standard.

The aim of the study is to confirm the good positioning of the tube with a lung ultrasonography.

After each intra-tracheal intubation, for patients with qualifying criteria, a lung ultrasonography will be performed, in bed, by two trained doctors (senior and junior) to determine if the position is right. Then, the chest radiography will be performed as usual.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient less than 18 years old
  • Patient intubated and ventilated
  • intubation probe considered in place on auscultation
  • SpO2> 92%
  • Affiliate or entitled to a social security scheme
  • No opposition of any of the parents.

排除标准

  • Children too unstable : decompensated shock
  • Spontaneous pneumothorax
  • Heart massage ongoing
  • Chest trauma
  • Faulty position of the probe intubation

结局指标

主要结局

Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography

时间窗: day of enrollment

correct position is defined by : * visualization of the probe intubation extremity in endotracheal * visualization of bilateral lung sliding

次要结局

  • Number of malpositions of the intubation probe evaluated with lung ultrasonography by senior evaluator(day of enrollment)
  • Number of mobilized intubation probes(day of enrollment)
  • Number of malpositions of the intubation probe evaluated with lung ultrasonography by junior evaluator(day of enrollment)
  • Number of patients with malposition of the oesophageal or selective intubation probe(day of enrollment)
  • Number of malpositions of the intubation probe evaluated with a chest radiography by junior evaluator(day of enrollment)
  • Number of malpositions of the intubation probe evaluated with a chest radiography by senior evaluator(day of enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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