跳至主要内容
临床试验/NCT00213395
NCT00213395终止不适用

Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure

University Hospital, Rouen2 个研究点 分布在 1 个国家开始时间: 2004年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
试验地点
2
主要终点
Arterial blood gases

研究概览

简要总结

Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.

Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations.

The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.

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

入选标准

  • Acute hypercapnic respiratory failure
  • Indication to noninvasive ventilation

排除标准

  • Requirement for endotracheal intubation
  • Proven pulmonary embolism
  • Present or previous history of ophthalmologic disease

结局指标

主要结局

Arterial blood gases

次要结局

  • Respiratory frequency
  • Severity scores
  • Ventilatory settings
  • Patient-ventilator adaptation
  • Tolerance
  • Outcome
  • Complications

研究者

发起方
University Hospital, Rouen
申办方类型
Other

研究点 (2)

Loading locations...

相似试验