NCT04532398

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

August 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

August 25, 2020

Last Update Submit

February 8, 2021

Conditions

Dysphagia

Keywords

Gugging swallowing screen - ICU (GUSS-ICU)Gugging swallowing screen (GUSS)multi-consistency checkFlexible Endoscopic Evaluation of Swallowing (FEES)

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (2)

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

    at baseline (up to 5 hours)

  • Validity of dysphagia severity

    at baseline (up to 5 hours)

Study Arms (1)

Swallowing test

OTHER
Other: Gugging swallowing screen - ICU (GUSS-ICU) index testOther: Flexible Endoscopic Evaluation of Swallowing (FEES) reference test

Interventions

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

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).

Swallowing test
Flexible Endoscopic Evaluation of Swallowing (FEES) reference testOTHER

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.

Swallowing test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Mini-Mental-State (MMS) Score \>/=24
  • signed informed consent

You may not qualify if:

  • not capable to follow study procedures (language problems, mental disorder)
  • end of life- patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Logopädie, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 37055724DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Fees and Charges

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and Organizations

Study Officials

  • Claudia Troll

    Logopädie (speech therapy), University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 31, 2020

Study Start

August 27, 2020

Primary Completion

February 8, 2021

Study Completion

February 8, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

CH(1)