Clinical trial NCT04532398: Validation of the Gugging Swallowing Screen for the Intensive Care Unit
Official title: Validation of the Gugging Swallowing Screen (GUSS-ICU) for the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Gugging swallowing screen - ICU (GUSS-ICU)
Gugging swallowing screen (GUSS)
multi-consistency check
Flexible Endoscopic Evaluation of Swallowing (FEES)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of GUSS-ICU (%)
timeFrame: at baseline (up to 5 hours)
measure: Specificity of GUSS-ICU (%)
timeFrame: at baseline (up to 5 hours)
Secondary outcomes:
measure: Interrater Reliability of GUSS-ICU (Cohen's Kappa statistical analysis)
timeFrame: at baseline (up to 5 hours)
measure: Validity of dysphagia severity
timeFrame: at baseline (up to 5 hours)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Logopädie, University Hospital Basel
Study officials:
affiliation: Logopädie (speech therapy), University Hospital Basel
name: Claudia Troll
role: PRINCIPAL_INVESTIGATOR
References: