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CompletedNCT04532398

Validation of the Gugging Swallowing Screen for the Intensive Care Unit

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERGugging swallowing screen - ICU (GUSS-ICU) index testGugging swallowing screen - ICU (GUSS-ICU) index test: Screening for post-extubation dysphagia: GUSS-ICU performed by 2 speech therapists independently. The GUSS-ICU model contains the core features of the original GUSS tool with the added assessment items specific to the ICU Patient (RASS score (Richmond Agitation and Sedation Scale)). Stage one of the screen focuses on the preliminary investigation of indirect swallowing. Stage two is comprised of varying steps that directly test swallowing. This would include the administration of semisolids, water and bread with four distinct signs that were being assessed for - deglutition, coughing, drooling and voice change. The GUSS test is evaluated using a points system (0-10) which determines the severity of dysphagia and recommends a diet form that largely minimizes the risk of aspiration. (e.g. 10 points: No dysphagia = normal food).
OTHERFlexible Endoscopic Evaluation of Swallowing (FEES) reference testFlexible Endoscopic Evaluation of Swallowing (FEES) reference test: Flexible Endoscopic Evaluation of Swallowing (FEES) is a technique to directly view the pharynx, larynx and esophagus during swallowing. The swallowing test is carried out first with saliva and then with different consistency (liquid, pulpy, solid) and different sized swallowing portions. This reference test is performed independently from the GUSS-ICU index test.

Timeline

Start date
2020-08-27
Primary completion
2021-02-08
Completion
2021-02-08
First posted
2020-08-31
Last updated
2021-02-09

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04532398. Inclusion in this directory is not an endorsement.