Validation of the Gugging Swallowing Screen for the Intensive Care Unit (GUSS-ICU)
Primary Purpose
Dysphagia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Gugging swallowing screen - ICU (GUSS-ICU) index test
Flexible Endoscopic Evaluation of Swallowing (FEES) reference test
Sponsored by
About this trial
This is an interventional other trial for Dysphagia focused on measuring Gugging swallowing screen - ICU (GUSS-ICU), Gugging swallowing screen (GUSS), multi-consistency check, Flexible Endoscopic Evaluation of Swallowing (FEES)
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
Sites / Locations
- Logopädie, University Hospital Basel
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Swallowing test
Arm Description
Outcomes
Primary Outcome Measures
Sensitivity of GUSS-ICU (%)
Sensitivity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)
Specificity of GUSS-ICU (%)
Specificity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)
Secondary Outcome Measures
Interrater Reliability of GUSS-ICU (Cohen's Kappa statistical analysis)
Interrater Reliability of GUSS-ICU for detection of dysphagia in ICU-patients after extubation
Validity of dysphagia severity
Validity of dysphagia severity (GUSS-ICU compared to FEES) by Spearman-correlation
Full Information
NCT ID
NCT04532398
First Posted
August 25, 2020
Last Updated
February 8, 2021
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT04532398
Brief Title
Validation of the Gugging Swallowing Screen for the Intensive Care Unit
Acronym
GUSS-ICU
Official Title
Validation of the Gugging Swallowing Screen (GUSS-ICU) for the Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
February 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Gugging swallowing screen - ICU (GUSS-ICU), Gugging swallowing screen (GUSS), multi-consistency check, Flexible Endoscopic Evaluation of Swallowing (FEES)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Swallowing test
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Gugging swallowing screen - ICU (GUSS-ICU) index test
Intervention Description
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
Intervention Name(s)
Flexible Endoscopic Evaluation of Swallowing (FEES) reference test
Intervention Description
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 Outcome Measure Information:
Title
Sensitivity of GUSS-ICU (%)
Description
Sensitivity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)
Time Frame
at baseline (up to 5 hours)
Title
Specificity of GUSS-ICU (%)
Description
Specificity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)
Time Frame
at baseline (up to 5 hours)
Secondary Outcome Measure Information:
Title
Interrater Reliability of GUSS-ICU (Cohen's Kappa statistical analysis)
Description
Interrater Reliability of GUSS-ICU for detection of dysphagia in ICU-patients after extubation
Time Frame
at baseline (up to 5 hours)
Title
Validity of dysphagia severity
Description
Validity of dysphagia severity (GUSS-ICU compared to FEES) by Spearman-correlation
Time Frame
at baseline (up to 5 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Troll
Organizational Affiliation
Logopädie (speech therapy), University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Logopädie, University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Validation of the Gugging Swallowing Screen for the Intensive Care Unit
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