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临床试验/NCT04532398
NCT04532398已完成不适用

Validation of the Gugging Swallowing Screen (GUSS-ICU) for the Intensive Care Unit

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年8月27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
45
试验地点
2
主要终点
Sensitivity of GUSS-ICU (%)

研究概览

简要总结

Aetiology of dysphagia after extubation is unknown and considered to be multifactorial. Use of a standardized dysphagia- screening permits an early diagnosis. This study is to evaluate a new GUSS (gugging swallowing Screen) tool with multi-consistency check for intensive care patients (GUSS-ICU) with dysphagia. The concurrent validity (in terms of sensitivity and specificity) of the GUSS-ICU is analyzed in comparison to the flexible endoscopic evaluation of swallowing (FEES).

详细描述

Aetiology of dysphagia after extubation is unknown and considered to be multifactorial. Use of a standardized dysphagia- screening permits an early diagnosis. This study is to evaluate a new GUSS (gugging swallowing Screen) tool with multi-consistency check for intensive care patients (GUSS-ICU) with dysphagia. The concurrent validity (in terms of sensitivity and specificity) of the GUSS-ICU is analyzed in comparison to the flexible endoscopic evaluation of swallowing (FEES).

The GUSS-ICU with multi-consistency check includes an indirect and a direct swallowing attempt. In indirect swallowing, the vigilance is first assessed on the basis of the RASS score (Richmond agitation-sedation scale), the presence of a stridor, the effectiveness of coughing and screeting, the possibility of swallowing saliva, drooling (saliva) and the change of voice after swallowing. If six points are reached, one can immediately proceed to the direct swallowing attempt. Unlike the original GUSS, the new GUSS-ICU direct swallowing test consists of 4 subtests with pulpy, liquid, solid and mixed solid-liquid consistency. The mixed solid-liquid consistency has been supplemented, as mixed consistencies require a more complex swallowing function with increased tongue- and lip coordination.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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 treated in ICU with intubation time of at least 24 hours
  • Richmond Agitation-Sedation Scale (RASS)-Score of 0 (alert and calm) to 2 (agitated)
  • Inclusion in study not earlier than 1 hour after extubation
  • Mini-Mental-State (MMS) Score >/=24
  • signed informed consent

排除标准

  • not capable to follow study procedures (language problems, mental disorder)
  • end of life- patients

结局指标

主要结局

Sensitivity of GUSS-ICU (%)

时间窗: at baseline (up to 5 hours)

Sensitivity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)

Specificity of GUSS-ICU (%)

时间窗: at baseline (up to 5 hours)

Specificity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)

次要结局

  • Interrater Reliability of GUSS-ICU (Cohen's Kappa statistical analysis)(at baseline (up to 5 hours))
  • Validity of dysphagia severity(at baseline (up to 5 hours))

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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