Validation of the Gugging Swallowing Screen for the Intensive Care Unit

Dysphagia Clinical Trial

— GUSS-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532398
• Other study ID #: 2020-01555; qu20Siegemund
• Status: Completed
• Phase: N/A
• Start date: August 27, 2020
• Est. completion date: February 8, 2021

Study information

• Verified date: February 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Other:
• Gugging 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).
• Flexible 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.

Locations

Country	Name	City	State
Switzerland	Logopädie, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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)