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临床试验/NCT05194761
NCT05194761Unknown不适用

Normal Saline Nebulization in Prevention of Extubation Failure in Neonates

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Reintubation by 72 hours post-extubation

研究概览

简要总结

this study is about evaluating the effect of using normal saline nebulization in preventing re-intubation in extubated neonates , provided that the cause of intubation is mainly due to respiratory cause

详细描述

Using nebulization is of great debate in neonates especially post extubation as neonates have physiological characteristics such as difficult airway maintenance and clearance, smaller airway caliber, compliant chest wall, poor airway stability, and lower functional residual capacity that account for the diminished delivery of inhaled aerosol.

Nebulized normal saline has historically been used as a placebo typically in studies examining bronchodilator medications and sputum expectorants or used as a carrier to medications. Nowadays, normal saline is a method of enhancing mucociliary clearance has become a clinically accepted adjunct to physiotherapy in the treatment of many chronic lung conditions .

the effect of whether or not nebulization really improves the lung condition is evaluated by lung ultrasound ,It is not only useful in predicting failure of non-invasive ventilation and the need for invasive ventilation, but also has a great value in anticipating extubation success In general, patients with lower lung ultrasound scores show a better chance of extubation success. Each lung will be divided into 3 areas (upper anterior, lower anterior, and lateral) and will be examined using a linear microprobe through both transverse and longitudinal scans. For each lung area, a 0- to 3-point score was given (total score ranging from 0-18).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 2 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Ventilated babies with primary respiratory disease as the provisional and primary cause of intubation immediately post-extubation.

排除标准

  • Neurological, cardiac, surgical or metabolic problems affecting their respiration.
  • Upper obstructive air way disease that might affect the success of extubation.

研究组 & 干预措施

using nebulization

Active Comparator

extubated neonates will be divided in two group , one will receive saline nebulization for 3 days postextubation ,

干预措施: Normal saline (Drug)

结局指标

主要结局

Reintubation by 72 hours post-extubation

时间窗: within 72 hours

Number of participants with successful extubation

次要结局

  • Lung ultrasound score(72 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olivia Zakaria ,MSC

principal investigator

Ain Shams University

研究点 (1)

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