DysphagiaGUSS-ICUNCT04532398

Validation of the Gugging Swallowing Screen for the Intensive Care Unit

A study testing Gugging swallowing screen - ICU (GUSS-ICU) index test and Flexible Endoscopic Evaluation of Swallowing (FEES) reference test in people with Dysphagia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dysphagia
What is being tested?: Gugging swallowing screen - ICU (GUSS-ICU) index test and Flexible Endoscopic Evaluation of Swallowing (FEES) reference test
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteSwitzerland
Study dates: 27 Aug 2020to 8 Feb 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Logopädie, University Hospital Basel
Basel, 4031

Other trials in Switzerland

About this study

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

Read the detailed description

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
Being tested: Gugging swallowing screen - ICU (GUSS-ICU) index test, Flexible Endoscopic Evaluation of Swallowing (FEES) reference test
Keywords: Gugging swallowing screen - ICU (GUSS-ICU), Gugging swallowing screen (GUSS), multi-consistency check, Flexible Endoscopic Evaluation of Swallowing (FEES)
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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).
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.

Study groups in NCT04532398
Study group	Role	What they receive
Swallowing test	Other	Not described Receives: Other: Gugging swallowing screen - ICU (GUSS-ICU) index test; Other: Flexible Endoscopic Evaluation of Swallowing (FEES) reference test

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity of GUSS-ICU (%)
Sensitivity of GUSS-ICU for detection of dysphagia in ICU-patients after extubation (compared to FEES)
Measured: 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)
Measured: at baseline (up to 5 hours)

Secondary outcomes (2)

Interrater Reliability of GUSS-ICU (Cohen's Kappa statistical analysis)
Interrater Reliability of GUSS-ICU for detection of dysphagia in ICU-patients after extubation
Measured: at baseline (up to 5 hours)
Validity of dysphagia severity
Validity of dysphagia severity (GUSS-ICU compared to FEES) by Spearman-correlation
Measured: at baseline (up to 5 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 20208 Feb 2021

First posted31 Aug 2020
Study start27 Aug 2020
Primary completion8 Feb 2021
Study completion8 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04532398
Sponsor's protocol ID: 2020-01555; qu20Siegemund
Acronym: GUSS-ICU
Status last verified: Feb 2021
First submitted: 25 Aug 2020
Last updated: 9 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37055724

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of the Gugging Swallowing Screen (GUSS-ICU) for the Intensive Care Unit
ClinicalTrials.gov ID: NCT04532398
Acronym / sponsor ID: GUSS-ICU / 2020-01555; qu20Siegemund
Conditions: Dysphagia
Keywords: Gugging swallowing screen - ICU (GUSS-ICU), Gugging swallowing screen (GUSS), multi-consistency check, Flexible Endoscopic Evaluation of Swallowing (FEES)
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: University Hospital, Basel, SwitzerlandUniversity, hospital or other
Study start: 27 Aug 2020 (actual)
Primary completion: 8 Feb 2021 (actual)
Study completion: 8 Feb 2021 (actual)
First posted: 31 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Swallowing test	Other	Other: Gugging swallowing screen - ICU (GUSS-ICU) index test, Other: Flexible Endoscopic Evaluation of Swallowing (FEES) reference test

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gugging swallowing screen - ICU (GUSS-ICU) index testGugging 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).	Other	Swallowing test
Flexible Endoscopic Evaluation of Swallowing (FEES) reference testFlexible 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.	Other	Swallowing test

Primary outcome

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)
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)

2 secondary outcomes

Interrater Reliability of GUSS-ICU (Cohen's Kappa statistical analysis)
Time frame: at baseline (up to 5 hours)
Validity of dysphagia severity
Time frame: at baseline (up to 5 hours)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
Derived from this study: PubMed 37055724Troll 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.

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Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claudia Troll principal investigator

Logopädie (speech therapy), University Hospital Basel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of GUSS-ICU (%) (time frame: at baseline (up to 5 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04532398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.