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Completed

NCT Number: NCT04532398

Validation of the Gugging Swallowing Screen for the Intensive Care Unit

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Logopädie, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

Primary outcomes

  1. Sensitivity of GUSS-ICU (%)

    Time frame: at baseline (up to 5 hours)

    Sensitivity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)

  2. Specificity of GUSS-ICU (%)

    Time frame: at baseline (up to 5 hours)

    Specificity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)

Secondary outcomes

  1. Interrater Reliability of GUSS-ICU (Cohen's Kappa statistical analysis)

    Time frame: at baseline (up to 5 hours)

    Interrater Reliability of GUSS-ICU for detection of dysphagia in ICU-patients after extubation

  2. Validity of dysphagia severity

    Time frame: at baseline (up to 5 hours)

    Validity of dysphagia severity (GUSS-ICU compared to FEES) by Spearman-correlation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: GUSS-ICU

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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