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临床试验/NCT01645358
NCT01645358已完成4 期

Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"

IRCCS Azienda Ospedaliero-Universitaria di Bologna4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
4
主要终点
Arterial Blood gases

研究概览

简要总结

Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated.

In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of 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

  • pH < 7,35 and PaCO2 > 45 mmHg
  • respiratory rate > 20 b/min

排除标准

  • hypoxic respiratory failure
  • inability to stand NIV
  • lack of informed consent

结局指标

主要结局

Arterial Blood gases

时间窗: at 1 hour after the start of NIV

次要结局

  • Arterial Blood Gases(Once a day at 8 am until discharge)

研究者

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

dr. Stefano Nava

Chief Respiratory and Critical care

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (4)

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