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临床试验/NCT05098834
NCT05098834尚未招募不适用

Assessment of Lung Volumes During Liberation From Mechanical Ventilation Using Electrical Impedance Tomography in Children

Duke University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
2
主要终点
Change in expiratory lung volume as measured by global lung electrical impedance

研究概览

简要总结

Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. The Extubation Readiness Test (ERT) is a simple evaluation commonly performed in the intensive care unit to determine if a child is ready to have the breathing tube removed.

The purpose of this study is to better understand how the ERT and the eventual removal of the breathing tube affect where the air is in the lungs, and whether this can help predict which children will succeed or fail having the breathing tube taken out. This can done be at the bedside with a device called electrical impedance tomograph. This novel device is painless and uses a belt fitted with sensors placed around the chest to show where the air is in the lungs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients less than 17 years of age admitted to the Duke Children's PICU or PCICU with acute respiratory failure due to a pulmonary illness will be considered eligible for the study

排除标准

  • Patients with corrected gestational age less than 37 weeks
  • Patients with contraindications to the ENLIGHT device (i.e. temporary or permanent pacemaker, vagal nerve stimulator, automatic implanted defibrillator, chest tubes that interfere with electrode belt placement, open chest wounds, unstable thorax, severe chest wall deformities)
  • known pregnancy
  • Patients previously enrolled in this study will be excluded from participation.

结局指标

主要结局

Change in expiratory lung volume as measured by global lung electrical impedance

时间窗: Baseline, 60 mins, 75 mins, 90 mins

次要结局

  • Percent of failed extubation as measured by need for re-intubation(Within 24 hours)
  • Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance(Baseline, 60 mins, 75 mins, 90 mins)
  • Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance(Baseline, 60 mins, 75 mins, 90 mins)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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