跳至主要内容
临床试验/NCT01518075
NCT01518075已完成不适用

Breathing-swallowing Interaction in Chronic Obstructive Pulmonary Disease (COPD) Patients Hospitalized in Intensive Care Unit for an Acute Exacerbation: Impact of Non Invasive Ventilation. Physiological Evaluation

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2012年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Impact of non invasive mechanical ventilation on breathing swallowing interaction

研究概览

简要总结

In the investigators' knowledge there are no data about the impact of non invasive mechanical ventilation on the breathing-swallowing interaction.

Our main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)

详细描述

In healthy subjects previous studies showed that most swallows started during expiration and were followed by expiration, a pattern believed to contribute to airway protection during swallowing. However In healthy individuals, the occurrence of inspiration after swallows was increased by hypercapnia or application of an inspiratory elastic load.

In a previous study the investigators have demonstrated that patients with neuromuscular disorders exhibited piecemeal deglutition leading to an increase in the time needed to swallow a water bolus, as well as occurrence of inspiration after nearly half the swallows. These abnormalities which increased with the decreasing of respiratory muscle performances may explain feeding difficulties. However in tracheostomized patients who could breathe spontaneously, piecemeal deglutition and swallowing time per bolus were diminished by the use of mechanical ventilation.

In the investigators' knowledge there are no data about the impact of non invasive mechanical ventilation on the breathing-swallowing interaction.

The investigators' main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • Patients with Chronic Obstructive Pulmonary Disease
  • Age > 18 years
  • Hospitalized in Intensive care for an acute exacerbation
  • Requiring Non invasive mechanical ventilation
  • Able to breath spontaneously without non invasive ventilation more than 4h/day
  • Without bulbar dysfunction

排除标准

  • Hemodynamic instability
  • Absence of consent
  • Severe Hypoxemia
  • pH < 7,30
  • No cooperation of the patient

研究组 & 干预措施

Non invasive mechanical ventilation

Experimental

Evaluation of breathing swallowing interaction under non invasive mechanical ventilation

干预措施: Non Invasive Mechanical Ventilation (Other)

Spontaneous Breathing

Active Comparator

Evaluation of breathing swallowing interaction without non invasive mechanical ventilation

干预措施: Spontaneous Breathing (Other)

结局指标

主要结局

Impact of non invasive mechanical ventilation on breathing swallowing interaction

时间窗: 2 h

Physiological evaluation of breathing - swallowing interaction with or without non invasive mechanical ventilation

次要结局

  • Correlation between breathing swallowing interaction and functional respiratory parameters(24 h)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Breathing-swallowing Interaction in Chronic... | 临床试验