跳至主要内容
临床试验/NCT03753841
NCT03753841已完成不适用

Flexible Endoscopic Evaluation of Swallowing (FEES) to Determine Neurological Patients' Oral Diet

University of Giessen2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2014年1月14日最近更新:
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
125
试验地点
2
主要终点
Pneumonia Rate

研究概览

简要总结

Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might reduce pneumonia rate, mortality and need for intubation/tracheotomy.

详细描述

Dysphagia, a common complication in neurological disorders, leads to high rates of mortality and morbidity. It is prevalent in critically ill patients, especially those who need mechanical ventilation. The investigators therefore investigate the effect of adjusting the oral diet of our intensive care unit (ICU) patients based on flexible endoscopic evaluation of swallowing (FEES) findings, thereby assessing the impact of FEES on a neurological ICU. All patients treated on the investigators neurological ICU will be eligible for this study.

The investigators will correlate findings with baseline data, disability status, pneumonia and duration of hospitalisation, as well as a need for mechanical ventilation or a tracheotomy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Treatment on neurological ICU
  • Clinical suspicion of Dysphagia

排除标准

  • 未提供

研究组 & 干预措施

Adjustment of oral diet

Active Comparator

Patients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet.

干预措施: Adjustment of oral diet (Other)

No adjustment of oral diet

No Intervention

Patients who have the adequat diet based on FEES findings.

结局指标

主要结局

Pneumonia Rate

时间窗: Up to 130 days

self-explanatory

Mortality

时间窗: Up to 130 days

self-explanatory

次要结局

  • Intubation/Tracheotomy(Up to 130 days)
  • Length of stay in hospital(Up to 130 days)

研究者

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

Tobias Braun

Principal Investigator

University of Giessen

研究点 (2)

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