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临床试验/NCT01791335
NCT01791335Unknown不适用

Effect of Noninvasive Ventilation on the Synchrony of the Upper Airways and Inspiration.

University Medical Center Nijmegen1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
The extent of glottis closure during diaphragm activation and the time delay in glottis opening with respect to diaphragm activity

研究概览

简要总结

Noninvasive ventilation (NIV) can provide ventilatory support in selected patients with acute respiratory failure, for instance due to acute exacerbation of COPD and acute heart failure. Advantages of noninvasive ventilation compared to invasive mechanical ventilation include absence of complications associated with endotracheal intubation, lower risk of pneumonia, lower level or even absence of sedation and the ability of the patient to verbally communicate. However, in approximately 30% of patients NIV fails and endotracheal intubation is needed to provide optimal ventilatory support. Surprisingly, very few studies have investigated why patients fail on NIV. Clinical observations indicated that agitation, delirium and most importantly asynchrony between patient and ventilator play a role in unsuccessful support with NIV. The upper airways are bypassed during endotracheal intubation. However, with NIV the upper airways may play a role in the efficiency of ventilatory support. In normal breathing the upper airways actively dilate before initiation of inspiratory flow. This is a highly appropriate response as it prevents narrowing of the upper airways during inspiration, which would result in elevated inspiratory resistance. Experiments in newborn lambs have shown that NIV has profound effects on physiology of the upper airways. Positive pressure during inspiration results in constriction of upper airway muscles in the early phase of inspiration. This results in elevated upper airway resistance with lower tidal volume delivered to the lungs. Subsequent studies revealed that reflexes that mediate this response originate in vagal afferences located in the lower airways. From an evolutionary point of view this might be an appropriate response, as high pressure delivered to the lungs may induce barotraumas. However, these responses may negatively affect the efficiency of ventilatory support delivered during NIV. The understanding of upper airway constriction and dilation during NIV is rudimentary. This study aims at determining the effect of NIV on regulation of upper airway patency in patients with COPD.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent
  • Hypercapnic respiratory acidosis
  • Clinical need of NIV ventilation on the intensive care
  • NAVA catheter in situ

排除标准

  • Pre-existent muscle disease (congenital or acquired) or diseases / disorders known to be associated with myopathy including auto-immune diseases.
  • Upper airway/esophageal/mouth or face pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
  • Recent (< 1 month) nasal bleeding
  • Allergic to xylocaïne

结局指标

主要结局

The extent of glottis closure during diaphragm activation and the time delay in glottis opening with respect to diaphragm activity

时间窗: 1 Day

次要结局

未报告次要终点

研究者

发起方
University Medical Center Nijmegen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leo Heunks

MD PhD

University Medical Center Nijmegen

研究点 (1)

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