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临床试验/NCT01024088
NCT01024088已完成不适用

Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Correlation between respiratory failure and bulbar dysfunction during ICU stay

研究概览

简要总结

To estimate, in a longitudinal and not invasive way, in patients with SGB at respiratory risk, the function of respiratory muscles and that of the upper airways muscles by investigating the force of the tongue, the gulp, and the breath during the sleep to be able to detect bulbar impairment and establish correlations enter the various parameters to estimate better the interactions between the dysfunction of the respiratory muscles and that upper airways muscles and so determine the risk acute respiratory failure.

详细描述

Context: the syndrome of Guillain Barré ( SGB) is the first causes of extensive paralysis of medical origin in industrial nations. A third of these patients going to require mechanical invasive ventilation during their stay in ICU. This population of ventilated presents the strongest risk of infectious respiratory patient complications and death. The respiratory impairment is a progressive weakness of inspiratory and expiratory muscles. The monitoring of the respiratory muscular infringement is usually made by the repeated measure of vital capacity and the maximal respiratory pressures. The occurrence of bulbar impairment is an aggravating element entailing dysfunction of the upper airways muscles detected often late in front of aspiration. Besides the arisen of sleep apneas was never sought in this context. This dysfunction of the upper airways muscles could be more detected prematurely by objectivizes measures of them performances.

Method: longitudinal observational and in a one center study. The respiratory impairment will be estimated by the measure of the vital capacity, maximal respiratory pressures and of the debit of cough. The existence of a bulbar infringement will be sought by the measure of the force of the tongue, an objective measure of gulp performances and a polysomnographic recording.

Criterion of selection: patient admitted in ICU with GBS and respiratory risk. Number of patients, centre: 40 patients admitted in the intensive care unit of the hospital RAYMOND POINCARE and 20 controls.

Duration of the study: 24 months Perspectives: better anticipate acute respiratory failure and the indication of an invasive ventilation.

研究设计

研究类型
Observational
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

  • Guillain Barré Syndrome
  • Presenting a risk of mechanical ventilation(breakdown): presence of 2 among the following 5 criteria
  • Deficit evolving for less than 7 days
  • Impossibility to stand up
  • Impossibility to raise the head
  • ineffective Cough
  • Vital capacity< 60 %

排除标准

  • MAJOR confusions of gulp (spontaneous) at admittance
  • Respiratory distress syndrome and intubation at admission buccal dental lesions
  • Not membership to a regime of Social Security (beneficiary or legal successor)
  • Patient under guardianship or custody

结局指标

主要结局

Correlation between respiratory failure and bulbar dysfunction during ICU stay

时间窗: 24 MONTHS

次要结局

  • Number of aspiration pneumonia(24 MONTHS)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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