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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04532398
Acronym
GUSS-ICU
Enrollment
45
Registered
2020-08-31
Start date
2020-08-27
Completion date
2021-02-08
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

Gugging swallowing screen - ICU (GUSS-ICU), Gugging swallowing screen (GUSS), multi-consistency check, Flexible Endoscopic Evaluation of Swallowing (FEES)

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.

Interventions

OTHERGugging swallowing screen - ICU (GUSS-ICU) index test

Gugging 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 test

Flexible 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.

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 severityat baseline (up to 5 hours)Validity of dysphagia severity (GUSS-ICU compared to FEES) by Spearman-correlation

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026