Validation of the Gugging Swallowing Screen for the Intensive Care Unit
- Conditions
- Dysphagia
- Interventions
- Other: Gugging swallowing screen - ICU (GUSS-ICU) index testOther: Flexible Endoscopic Evaluation of Swallowing (FEES) reference test
- Registration Number
- NCT04532398
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
- not capable to follow study procedures (language problems, mental disorder)
- end of life- patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Swallowing test Gugging swallowing screen - ICU (GUSS-ICU) index test - Swallowing test Flexible Endoscopic Evaluation of Swallowing (FEES) reference test -
- Primary Outcome Measures
Name Time Method Sensitivity of GUSS-ICU (%) 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 (%) at baseline (up to 5 hours) Specificity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)
- Secondary Outcome Measures
Name Time Method Interrater Reliability of GUSS-ICU (Cohen's Kappa statistical analysis) at baseline (up to 5 hours) Interrater Reliability of GUSS-ICU for detection of dysphagia in ICU-patients after extubation
Validity of dysphagia severity at baseline (up to 5 hours) Validity of dysphagia severity (GUSS-ICU compared to FEES) by Spearman-correlation
Trial Locations
- Locations (1)
Logopädie, University Hospital Basel
🇨🇭Basel, Switzerland