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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04532398
Other study ID # 2020-01555; qu20Siegemund
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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