Dysphagia Clinical Trial
— GUSS-ICUOfficial title:
Validation of the Gugging Swallowing Screen (GUSS-ICU) for the Intensive Care Unit
Verified date | February 2021 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 45 |
Est. completion date | February 8, 2021 |
Est. primary completion date | February 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - not capable to follow study procedures (language problems, mental disorder) - end of life- patients |
Country | Name | City | State |
---|---|---|---|
Switzerland | Logopädie, University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of GUSS-ICU (%) | Sensitivity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES) | at baseline (up to 5 hours) | |
Primary | Specificity of GUSS-ICU (%) | Specificity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES) | at baseline (up to 5 hours) | |
Secondary | Interrater Reliability of GUSS-ICU (Cohen's Kappa statistical analysis) | Interrater Reliability of GUSS-ICU for detection of dysphagia in ICU-patients after extubation | at baseline (up to 5 hours) | |
Secondary | Validity of dysphagia severity | Validity of dysphagia severity (GUSS-ICU compared to FEES) by Spearman-correlation | at baseline (up to 5 hours) |
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