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GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients

Evaluation of the Effects of Using the GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07195383
Enrollment
82
Registered
2025-09-26
Start date
2025-03-05
Completion date
2026-06-30
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization

Keywords

DYSPHAGIA, ICU, POST- EXTUBATION

Brief 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. 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.

Interventions

OTHERNutrion plan based on GUSS-ICU scale

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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

* 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 * 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).

Design outcomes

Primary

MeasureTime frameDescription
Change in the frequency of GI symptoms in intensive care patients who received a post-extubation GUSS-ICU safe nutrition programOn the 1st and 4th days after extubationChanges 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.
Change in the incidence of aspiration pneumonia in intensive care patients receiving a GUSS-ICU safe nutrition program after extubationOn the 1st and 4th days after extubationThe data in the patient follow-up form will be evaluated with the clinician's supervision.
Changes in malnutrition risk scores and findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubationOn the 1st and 4th days after extubationChanges 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 extubationOn the 1st and 4th days after extubationDehydration 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.

Secondary

MeasureTime frameDescription
Change in Scored Patient-Generated Subjective Global Assessment (PG-SGA) scoreOn the 1st and 4th days after extubationPossible effects on nutrition will be evaluated using the Scored Patient-Generated Subjective Global Assessment (PG-SGA).
Change in Modified Nutrition Risk in the Critically Ill (m-NUTRIC) scoreOn the 1st and 4th days after extubationIt will be assessed with the Modified Nutrition Risk in the Critically Ill (m-NUTRIC) score.
Change in APACHE II scoreOn the 1st and 4th days after extubationThe effects on mortality will be evaluated with the APACHE II score.
Change in SOFA (Sequential Organ Failure Assessment) ScoreOn the 1st and 4th days after extubationSOFA (Sequential Organ Failure Assessment) Score will be evaluated to determine the effects on mortality.

Other

MeasureTime frameDescription
Change in the number of days from tube feeding to oral feedingFrom the first to the last day of follow-up after extubationChange in the number of days from tube feeding to oral feeding
Change in oral intake (calorie)From the first to the last day of follow-up after extubationChange in oral intake (calorie)

Countries

Turkey (Türkiye)

Contacts

Primary ContactMerve TURKAY
turkay_merve@hotmail.com+905313793706
Backup ContactZeliha TÜLEK
tulekz@yahoo.com+905327762993

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026