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临床试验/NCT01056939
NCT01056939已完成不适用

Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

University of Oulu1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2009年9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
170
试验地点
1
主要终点
Primary outcome is the duration of mechanical ventilation

研究概览

简要总结

The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not.

The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration more accurately than currently used methods, and thus will lead to more smooth adaptation to mechanical ventilation in pediatric patients. The investigators expect this to decrease the time of ventilatory support needed.

详细描述

Asynchrony means that the timing of support given by ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.

In our study we randomly treat pediatric patients needing ventilatory support with neurally adjusted ventilatory assist and pressure controlled or PRVC-ventilation. We are willing to find out if there are any special benefits for patients with each treatment mode.

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 Minute 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children from term newborn (37+0 gestational week) to 16-year-old needing ventilatory care at least 30 minutes

排除标准

  • Any condition that prevents feeding tube positioning. Critical ventilatory or perfusion problems.

结局指标

主要结局

Primary outcome is the duration of mechanical ventilation

时间窗: 30minutes-3weeks

次要结局

  • Amount of sedative medication needed(30minutes-3weeks)

研究者

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

Merja Ålander

MD

University of Oulu

研究点 (1)

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