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临床试验/NCT01839474
NCT01839474已完成不适用

Clinical Trial Evaluating the Difference in Mortality Rates in Children in Ghana Receiving CPAP Versus Those Who Do Not

Columbia University2 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2014年1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
2,200
试验地点
2
主要终点
All cause mortality

研究概览

简要总结

The purpose of this study is to determine if the use of a continuous positive airway pressure (CPAP) machine (a device that blows air into the lungs) decreases the chance of a child dying from difficulty breathing.

详细描述

Acute respiratory infections, malaria, and sepsis remain leading causes of death in children throughout the world.These conditions may lead to respiratory distress and eventually failure if not adequately managed. In developing countries with limited resources, advanced airway management and support can be challenging and needs to be approached in a different manner than is done in developed nations. For example, the use of invasive mechanical ventilation for respiratory distress is not an option in many resource-limited countries due to the lack of available technology, infrastructure, and trained personnel. Other alternatives should be utilized in order to support children with reversible conditions during their acute respiratory distress stage. One such alternative is non-invasive positive pressure.

Prior research demonstrated that nasal bubble CPAP can be successfully introduced and utilized in a developing country's emergency ward. Nurses in four Ghanaian district hospital emergency wards (Kintampo, Mampong,Nkoranza, and Wenchi) were able to safely apply CPAP and monitor the patient's response. The investigators demonstrated that patients receiving CPAP had a significant decrease in respiratory rate compared with those that did not with a mean difference of 14 breaths per minute. There were no major side effects associated with the use of CPAP. Now that CPAP has demonstrated to decrease respiratory rate in a non-specific disease population presenting with respiratory distress it is important to determine if it also improves survival. Therefore, the purpose of the study is to determine if the use of CPAP in children 1 month to 5 years of age with respiratory distress decreases mortality.

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
1 Month 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • One month to five years of age
  • Respiratory rate (RR) greater than 50 breaths per minute in three months to one year of age, and greater than 40 breaths per minute in one to five years of age
  • Presence of sub costal, intercostal, supraclavicular retractions or nasal flaring

排除标准

  • Age less than one month or older than five years
  • Skin breakdown around nose/mouth or facial trauma
  • Unable to protect airway
  • Uncontrollable emesis
  • Unresponsiveness
  • poor respiratory effort requiring positive pressure ventilation or invasive mechanical ventilation for respiratory failure
  • known or suspected pneumothorax

结局指标

主要结局

All cause mortality

时间窗: 2 weeks

The primary outcome will be 2 week mortality rate in children receiving CPAP and standard therapy compared with children receiving standard therapy alone.

次要结局

  • Respiratory rate(24 hours)

研究者

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

Rachel Moresky

Assistant Clinical Professor of Population & Family Health and Medicine

Columbia University

研究点 (2)

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