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临床试验/NCT01090544
NCT01090544已完成不适用

Transnasal Insufflation for Patients With COPD GOLD IV and Hypercapnia

Helios Klinik Ambrock2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2009年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
partial pressure of carbon dioxide (PaCO2) decrease

研究概览

简要总结

The purpose of this study is to determine wether transnasal insufflation as an alternate form of breathing support for COPD patients will lead to improvement of their medical condition.

详细描述

Chronic obstructive pulmonary disease (COPD) is a slowly proceeding lung disease which basic pathophysiologic mechanisms are only partly understood so far and which is difficult to access with a pharmacological or sundry approach besides smoking cessation. Average life expectancy is clearly limited especially in advanced stages with respiratory insufficiency . Based on different smaller surveys long-term oxygen treatment is classified to be the routine in COPD treatment when patients develop hypoxemia.

The primary application of non-invasive ventilation Routine is the treatment for COPD patients with acute respiratory decompensation and developing hypoxemia and respiratory acidosis, because it reduces the acute mortality as various prospective randomized studies showed.

On the other side there are no distinct informations and data about the initiation of a nocturnal positive pressure breathing therapy when chronic hypercapnia appear in progression of COPD.

Nocturnal positive pressure therapy appliqued with a mask can be assumed to be the routine treatment for neuromuscular and restrictive thorax diseases, because nocturnal ventilation results in a distinct increase of life expectancy.

In contrast data about positive pressure therapy at COPD are inconsistent and initiation of nocturnal breathing therapy is practised in many places, but is scientifically not confirmed yet.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD GOLD IV
  • PCO2 > 50 mmHg
  • competent patients
  • stable respiratory situation

排除标准

  • serious acute diseases
  • hypercapnic decompensation pH < 7,30

结局指标

主要结局

partial pressure of carbon dioxide (PaCO2) decrease

时间窗: 3 hours

PaCO2 is measured before and after applying TNI, and a PaCO2 decrease is supposed to be assessed.

次要结局

  • Breathing Frequency(3 hours)

研究者

发起方
Helios Klinik Ambrock
申办方类型
Other

研究点 (2)

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