Validation of the Gugging Swallowing Screen for the Intensive Care Unit

NCT ID: NCT04532398

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-27
• Study Completion Date: 2021-02-08

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.

Conditions

Dysphagia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Swallowing test

Group Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia Troll

Role: PRINCIPAL_INVESTIGATOR

Logopädie (speech therapy), University Hospital Basel

Locations

Logopädie, University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

Troll C, Trapl-Grundschober M, Teuschl Y, Cerrito A, Compte MG, Siegemund M. A bedside swallowing screen for the identification of post-extubation dysphagia on the intensive care unit - validation of the Gugging Swallowing Screen (GUSS)-ICU. BMC Anesthesiol. 2023 Apr 13;23(1):122. doi: 10.1186/s12871-023-02072-6.

Reference Type: DERIVED

PMID: 37055724 (View on PubMed)

Other Identifiers

2020-01555; qu20Siegemund

Identifier Type: -

Identifier Source: org_study_id