DysphagiaNCT07195383
GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients
A study testing Nutrion plan based on GUSS-ICU scale in people with Dysphagia and Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of using the GUSS-ICU Safe Nutrition Program after extubation in Intensive Care Unit patients. This randomized controlled trial will be conducted in the Anesthesia Intensive Care Unit of Bakırköy Dr. Sadi Konuk Training and Research Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization
- What is being tested?
- Nutrion plan based on GUSS-ICU scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Mar 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 and over Patients expected to remain intubated for more than 24 hours. Patients who have been extubated for no more than 4 hours.
Who cannot join
- Patients with neuromuscular disease
- Patients requiring non-invasive ventilation for more than 6 hours after extubation
- Patients being followed in the terminal phase
- Patients with a tracheostomy cannula
- Patients with a history of dysphagia
- Patients with head/neck cancer or surgery
Show all 9Show fewer
- Patients with existing facial fractures
- Patients with a RASS score not within the 0-2 range
- Patients at high risk of bleeding (INR ≥ 2.0, Platelet count ≤ 50,000).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul
+90(212) 414 71 71, istanbuleah3.biis@saglik.gov.tr
Oya Hergünsel
- Recruiting
Istanbul Universitesi-Cerrahpasa
Istanbul
About this study
Official title: Evaluation of the Effects of Using the GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients
The aim of this study is to evaluate the effects of using the GUSS-ICU Safe Nutrition Program after extubation in Intensive Care Unit patients. This randomized controlled trial will be conducted in the Anesthesia Intensive Care Unit of Bakırköy Dr. Sadi Konuk Training and Research Hospital. Eligible participants will be randomly assigned to either the control group (usual care/routine follow-up group) or the intervention group (GUSS-ICU patients). Patients undergoing GUSS-ICU assessment will continue the nutritional program, as directed by the scale, for four days. Data are recorded on the first and last day. The data will then be evaluated in conjunction with the control group data.
Read the detailed description
The aim of this study is to evaluate the effects of using the GUSS-ICU Safe Nutrition Program after extubation in intensive care patients. This randomized controlled trial will be conducted in the Anesthesia Intensive Care Unit of Bakırköy Dr. Sadi Konuk Training and Research Hospital. Patients who meet the criteria will be randomized into either an intervention group or a control group. Patients in the control group will receive routine post-extubation care, follow-up, and a nutrition plan. On day 1, baseline data will be collected using the m-NUTRIC score, APACHE-II, SOFA, Charlson Comorbidity Index (CCI), Scored Patient-Generated Subjective Global Assessment (PG-SGA), and a patient data form. Routine follow-up and nutrition plans will be continued. At the end of day 4, the m-NUTRIC score, APACHE-II, SOFA, Charlson Comorbidity Index (CCI), Scored Patient-Generated Subjective Global Assessment (PG-SGA), and a patient data form will be completed. Patients in the intervention group undergo a GUSS-ICU assessment within the first 4 hours after extubation. Nutrition planning is based on the assessment scores. On day 1, baseline data includes the m-NUTRIC score, APACHE-II, SOFA, Charlson Comorbidity Index (CCI), Scored Patient-Generated Subjective Global Assessment (PG-SGA), and a patient data form. Nutritional monitoring and follow-up are continued for 4 days. At the end of day 4, the m-NUTRIC score, APACHE-II, SOFA, Charlson Comorbidity Index (CCI), Scored Patient-Generated Subjective Global Assessment (PG-SGA), and a patient data form are completed. The data will then be evaluated in conjunction with the control group data.
- Conditions
- Dysphagia, Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization
- Being tested
- Nutrion plan based on GUSS-ICU scale
- Keywords
- DYSPHAGIA, ICU, POST- EXTUBATION
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrion plan based on GUSS-ICU scaleOther
Also called Use of the GUSS-ICU scale after extubation
To ensure a rapid and accurate transition to post-extubation nutrition, patients will be assessed using the GUSS-ICU scale at 4 hours after extubation. A nutrition plan will be created based on the patient's GUSS-ICU score and will be maintained for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| GUSS-ICU Applied Group | Experimental | The GUSS-ICU Scale, which is used for the transition to feeding of extubated patients, will be applied to the randomly selected intervention group included in the study, and feeding will be planned and continued for 4 days according to the score achieved. Receives: Other: Nutrion plan based on GUSS-ICU scale |
| Routine Follow-up Group | No intervention | Routine care and follow-up will be applied to the randomly selected control group for 4 days after extubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in malnutrition risk scores and findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation
Changes in malnutrition risk scores and findings in intensive care patients who received the GUSS-ICU Safe Nutrition Program after extubation will be evaluated with the PG-SGA.
Measured: On the 1st and 4th days after extubation
Changes in dehydration findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation
Dehydration findings in intensive care patients who are applied GUSS-ICU Safe Nutrition Program after extubation will be evaluated with PG-SGA and patient data form.
Measured: On the 1st and 4th days after extubation
Change in the incidence of aspiration pneumonia in intensive care patients receiving a GUSS-ICU safe nutrition program after extubation
The data in the patient follow-up form will be evaluated with the clinician's supervision.
Measured: On the 1st and 4th days after extubation
Change in the frequency of GI symptoms in intensive care patients who received a post-extubation GUSS-ICU safe nutrition program
Changes in the frequency of GI symptoms in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation will be evaluated with PG-SGA and Patient Data Form.
Measured: On the 1st and 4th days after extubation
Secondary outcomes (4)
Change in Modified Nutrition Risk in the Critically Ill (m-NUTRIC) score
It will be assessed with the Modified Nutrition Risk in the Critically Ill (m-NUTRIC) score.
Measured: On the 1st and 4th days after extubation
Change in APACHE II score
The effects on mortality will be evaluated with the APACHE II score.
Measured: On the 1st and 4th days after extubation
Change in SOFA (Sequential Organ Failure Assessment) Score
SOFA (Sequential Organ Failure Assessment) Score will be evaluated to determine the effects on mortality.
Measured: On the 1st and 4th days after extubation
Change in Scored Patient-Generated Subjective Global Assessment (PG-SGA) score
Possible effects on nutrition will be evaluated using the Scored Patient-Generated Subjective Global Assessment (PG-SGA).
Measured: On the 1st and 4th days after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start5 Mar 2025
- Primary completion5 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
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 Istanbul University - CerrahpasaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Tülek, Istanbul University - Cerrahpasa
- Investigators
- Merve TURKAY, Principal investigator, Istanbul Universitesi-CerrahpasaZeliha TÜLEK, Study director, Istanbul Universitesi-Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195383
- Sponsor's protocol ID
- E-74555795-050.04-1249240
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Using the GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients
- ClinicalTrials.gov ID
- NCT07195383
- Acronym / sponsor ID
- E-74555795-050.04-1249240
- Conditions
- Dysphagia, Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization
- Keywords
- DYSPHAGIA, ICU, POST- EXTUBATION
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 5 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Sep 2025 (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.
The aim of this study is to evaluate the effects of using the GUSS-ICU Safe Nutrition Program after extubation in Intensive Care Unit patients. This randomized controlled trial will be conducted in the Anesthesia Intensive Care Unit of Bakırköy Dr. Sadi Konuk Training and Research Hospital. Eligible participants will be randomly assigned to either the control group (usual care/routine follow-up group) or the intervention group (GUSS-ICU patients). Patients undergoing GUSS-ICU assessment will continue the nutritional program, as directed by the scale, for four days. Data are recorded on the first and last day. The data will then be evaluated in conjunction with the control group data.
Detailed description
The aim of this study is to evaluate the effects of using the GUSS-ICU Safe Nutrition Program after extubation in intensive care patients. This randomized controlled trial will be conducted in the Anesthesia Intensive Care Unit of Bakırköy Dr. Sadi Konuk Training and Research Hospital. Patients who meet the criteria will be randomized into either an intervention group or a control group. Patients in the control group will receive routine post-extubation care, follow-up, and a nutrition plan. On day 1, baseline data will be collected using the m-NUTRIC score, APACHE-II, SOFA, Charlson Comorbidity Index (CCI), Scored Patient-Generated Subjective Global Assessment (PG-SGA), and a patient data form. Routine follow-up and nutrition plans will be continued. At the end of day 4, the m-NUTRIC score, APACHE-II, SOFA, Charlson Comorbidity Index (CCI), Scored Patient-Generated Subjective Global Assessment (PG-SGA), and a patient data form will be completed. Patients in the intervention group undergo a GUSS-ICU assessment within the first 4 hours after extubation. Nutrition planning is based on the assessment scores. On day 1, baseline data includes the m-NUTRIC score, APACHE-II, SOFA, Charlson Comorbidity Index (CCI), Scored Patient-Generated Subjective Global Assessment (PG-SGA), and a patient data form. Nutritional monitoring and follow-up are continued for 4 days. At the end of day 4, the m-NUTRIC score, APACHE-II, SOFA, Charlson Comorbidity Index (CCI), Scored Patient-Generated Subjective Global Assessment (PG-SGA), and a patient data form are completed. The data will then be evaluated in conjunction with the control group data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GUSS-ICU Applied Group | Experimental | Other: Nutrion plan based on GUSS-ICU scaleThe GUSS-ICU Scale, which is used for the transition to feeding of extubated patients, will be applied to the randomly selected intervention group included in the study, and feeding will be planned and continued for 4 days according to the score achieved. |
| Routine Follow-up Group | No intervention | –Routine care and follow-up will be applied to the randomly selected control group for 4 days after extubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 and over Patients expected to remain intubated for more than 24 hours. Patients who have been extubated for no more than 4 hours.
Key exclusion criteria (9 listed)
- Patients with neuromuscular disease
- Patients requiring non-invasive ventilation for more than 6 hours after extubation
- Patients being followed in the terminal phase
- Patients with a tracheostomy cannula
- Patients with a history of dysphagia
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 |
|---|---|---|
| Nutrion plan based on GUSS-ICU scaleAlso: Use of the GUSS-ICU scale after extubationTo ensure a rapid and accurate transition to post-extubation nutrition, patients will be assessed using the GUSS-ICU scale at 4 hours after extubation. A nutrition plan will be created based on the patient's GUSS-ICU score and will be maintained for 4 days. | Other | GUSS-ICU Applied Group |
Primary outcome
Changes in malnutrition risk scores and findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation
Time frame: On the 1st and 4th days after extubation
Changes in malnutrition risk scores and findings in intensive care patients who received the GUSS-ICU Safe Nutrition Program after extubation will be evaluated with the PG-SGA.
Changes in dehydration findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation
Time frame: On the 1st and 4th days after extubation
Dehydration findings in intensive care patients who are applied GUSS-ICU Safe Nutrition Program after extubation will be evaluated with PG-SGA and patient data form.
Change in the incidence of aspiration pneumonia in intensive care patients receiving a GUSS-ICU safe nutrition program after extubation
Time frame: On the 1st and 4th days after extubation
The data in the patient follow-up form will be evaluated with the clinician's supervision.
Change in the frequency of GI symptoms in intensive care patients who received a post-extubation GUSS-ICU safe nutrition program
Time frame: On the 1st and 4th days after extubation
Changes in the frequency of GI symptoms in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation will be evaluated with PG-SGA and Patient Data Form.
4 secondary outcomes
Change in Modified Nutrition Risk in the Critically Ill (m-NUTRIC) score
Time frame: On the 1st and 4th days after extubation
Change in APACHE II score
Time frame: On the 1st and 4th days after extubation
Change in SOFA (Sequential Organ Failure Assessment) Score
Time frame: On the 1st and 4th days after extubation
Change in Scored Patient-Generated Subjective Global Assessment (PG-SGA) score
Time frame: On the 1st and 4th days after extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
Merve TURKAY principal investigator
Istanbul Universitesi-Cerrahpasa
Zeliha TÜLEK study director
Istanbul Universitesi-Cerrahpasa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrion plan based on GUSS-ICU scale in people with Dysphagia and Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
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 1 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve TURKAY (+905313793706, turkay_merve@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in malnutrition risk scores and findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation (time frame: On the 1st and 4th days after extubation). The study lists 4 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 NCT07195383, 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 26 Sep 2025.