GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients

NCT07195383 | Recruiting

• 1 other identifier: E-74555795-050.04-1249240
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

DYSPHAGIA; ICU; POST- EXTUBATION

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  On the 1st and 4th days after extubation

Secondary Outcomes (4)

• Change in Modified Nutrition Risk in the Critically Ill (m-NUTRIC) score

  On the 1st and 4th days after extubation

• Change in APACHE II score

  On the 1st and 4th days after extubation

• Change in SOFA (Sequential Organ Failure Assessment) Score

  On the 1st and 4th days after extubation

• Change in Scored Patient-Generated Subjective Global Assessment (PG-SGA) score

  On the 1st and 4th days after extubation

Other Outcomes (2)

• Change in the number of days from tube feeding to oral feeding

  From the first to the last day of follow-up after extubation

• Change in oral intake (calorie)

  From the first to the last day of follow-up after extubation

Study Arms (2)

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.

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.

Interventions

Nutrion plan based on GUSS-ICU scale OTHER

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.

Also known as: Use of the GUSS-ICU scale after extubation

GUSS-ICU Applied Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi-Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Dhuley JN, Naik SR. Moderate protective effect of 6-MFA, a microbial metabolite obtained from Aspergillus ochraceus on immunological liver injury in mice. Comp Immunol Microbiol Infect Dis. 1999 Jan;22(1):15-25. doi: 10.1016/s0147-9571(98)00021-6.

  PMID: 10099025 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Merve TURKAY

  Istanbul Universitesi-Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Zeliha TÜLEK

  Istanbul Universitesi-Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Merve TURKAY

CONTACT

+905313793706; turkay_merve@hotmail.com

Zeliha TÜLEK

CONTACT

+905327762993; tulekz@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 26, 2025
• Study Start: March 5, 2025
• Primary Completion: March 5, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)