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临床试验/NCT04011852
NCT04011852已完成不适用

The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2019年9月26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
83
试验地点
1
主要终点
Correlate Electrical impedance tomography to Extubation failure

研究概览

简要总结

To correlate the data obtained by Electrical impedance tomography (EIT) during the spontaneous breathing trials (SBT) on a T-piece, in children, with failure in the trial and Extubation failure.

Observe if the EIT monitoring will be able to detect the children that will fail earlier than the SBT performed alone.

Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning.

详细描述

Early and successful Extubation is sometimes a difficult combination in children, since the criteria for suggesting it are often subjective and poorly defined. Electrical impedance tomography (EIT) has been developed and used clinically for more than 30 years. Interest in this technology arose from the need to monitor ventilation and pulmonary perfusion at the bedside. Because it is a non-invasive and non-radiation technology, EIT is very promising in the pediatric population. Objectives: To correlate the data obtained by the EIT during the spontaneous breathing trials (SBT) on a T-piece with failure in the trial and Extubation failure and to observe if the EIT is able to detect the children that will fail earlier than the SBT performed alone. Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning. Qualitative characteristics will be described using absolute and relative frequencies and the quantitative characteristics will be described using summary measures (mean, standard deviation, median, minimum and maximum). Bivariate and later multiple logistic regression analyzes will be performed to evaluate the influence of characteristics assessed on weaning failure, mainly the reduction in functional residual capacity during and after the weaning trial. For the analysis will be used the software IBM-SPSS for Windows version 20.0 and tabulation of the data will be used Microsoft Excel 2010 software. The tests will be performed with significance level of 5%.

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
28 Days 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who are on mechanical ventilation for a period of more than 24 hours, between 28 days of age and 15 years, who are admitted to the pediatric intensive care unit (ICU) of the Children's Institute in Brazil

排除标准

  • Upper Airway Obstruction
  • Diaphragmatic hernia or diaphragmatic paralysis
  • Chronic use of mechanical ventilation
  • Cyanogenic congenital heart disease
  • Primary pulmonary hypertension
  • Neuromuscular disease
  • Tracheostomy

结局指标

主要结局

Correlate Electrical impedance tomography to Extubation failure

时间窗: 48 hours

Compare data obtained by the EIT during the spontaneous breathing trial with Extubation failure

Correlate Electrical impedance tomography to spontaneous breathing trial failure

时间窗: 1 hour

Observe if Electrical impedance tomography detects children who will fail in spontaneous breathing trial (during a 1-hour T-piece) earlier than clinical criteria

次要结局

  • Electrical impedance tomography Security(2 hours)
  • Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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