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临床试验/NCT00780078
NCT00780078已完成不适用

Clinical Evaluation by Physical Therapist of Swallowing Disorders as a Predictor of Extubation Failure in Patients Intubated Orotracheally for Over 6 Days

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2008年10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
160
试验地点
1
主要终点
Rate of reintubation within the 72 hours after extubation

研究概览

简要总结

Patients with failed extubation stay significantly longer in an intensive care unit (ICU) and have a higher mortality rate, than those intubated successfully. Reintubation is associated with life-threatening complications and a poor prognosis. Functional respiratory tests are frequently used as weaning parameters, however, they are not accurate enough to predict extubation failure. The incidence of swallowing dysfunction is underestimated, mainly among patients whose intubation lasts longer than 48 h.We previously observed that the assessment of the swallowing function and oropharyngeal motricity, conducted by the physiotherapist before extubation could be helpful for making decisions to extubate patients intubated for over 6 days. The objective of this study is to validate a scale previously devised and used for physiotherapist bedside evaluation of the swallowing function and oropharyngeal motricity, among patients intubated for over 6 days, to determine whether this scale is a good predictor of airway secretion-related extubation failure.Expected results : to validate a scale previously devised called " physiotherapist evaluation of the swallowing function and oropharyngeal motricity before extubation" by the mean of a multicentric study. In our hypothesis the clinical parameters studied could be predictive of extubation failure. Then, this evaluation could help the medical decision in the choice of the good time for extubation. The final objective is to lower the mortality related to extubation failure.

详细描述

  • Patients selection, inclusion and procedure: All successive patients admitted to the medical or surgical ICU, and intubated by the orotracheal route for >6 days, will be prospectively enrolled when extubation will be decided. Patients with previous swallowing disorders, ENT surgery or chronic persistent vegetative status will not be included. All patients will have to fulfill the usual criteria for extubation. Then, before extubation, the different components of swallowing functions will be evaluated by the trained physiotherapist, using a bedside pre-extubation scale based on 3 tests: assessment of 1)- cervical, oral, labial and lingual motricity; 2)- the gag reflex; and 3)- swallowing. After extubation, the ability to cough and swallow, secretion volume, and the need for suctioning will be evaluated immediately, then at 24, 48 and 72 hours.
  • Expected results : to validate a scale previously devised called " physiotherapist evaluation of the swallowing function and oropharyngeal motricity before extubation" by the mean of a multicentric study. In our hypothesis the clinical parameters studied could be predictive of extubation failure. Then, this evaluation could help the medical decision in the choice of the good time for extubation. The final objective is to lower the mortality related to extubation failure.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • age over 18 years
  • patients intubated orotracheally for over 6 days
  • patients fulfilling usual medical criteria for extubation, after a successful test of spontaneous ventilation, according to the French consensus conference (2001).

排除标准

  • post ENT surgery- previous swallowing disorders
  • chronic vegetative status

结局指标

主要结局

Rate of reintubation within the 72 hours after extubation

时间窗: 72 hours after extubation

次要结局

  • Delay for reintubation (hours)(72 hours after extubation)
  • Number of daily pharyngeal or tracheal suctioning(72 hours after extubation)
  • Mortality(7 days)
  • Pulmonary infection(72 hours after extubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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