GUSS-ICU safe nutrition plan for patients after extubation
Evaluation of the Effects of Using the GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients
NA · Istanbul University - Cerrahpasa · NCT07195383
This trial will test whether using the GUSS-ICU feeding plan for adults who were just taken off a breathing tube improves nutrition and swallowing safety compared with routine care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa (other) |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT07195383 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial conducted in the anesthesia intensive care units in Istanbul where eligible adults recently extubated (within 4 hours) are assigned to either routine post-extubation care or a GUSS-ICU–guided nutrition program. Patients in the intervention arm receive a GUSS-ICU swallowing assessment shortly after extubation and a nutrition plan based on the score, with monitoring continued for four days. Baseline and day-4 measures include m-NUTRIC, APACHE-II, SOFA, Charlson Comorbidity Index, and PG-SGA alongside a patient data form. Patients with neuromuscular disease, tracheostomy, recent head/neck surgery, prior dysphagia, high bleeding risk, or prolonged noninvasive ventilation are excluded.
Who should consider this trial
Good fit: Adults (age ≥18) who were intubated >24 hours and have been extubated within the past 4 hours, with a RASS score in the 0–2 range, are ideal candidates for enrollment.
Not a fit: Patients with neuromuscular disease, tracheostomy, recent head or neck cancer/surgery, prior dysphagia, high bleeding risk, or those needing prolonged noninvasive ventilation are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the program could make post-extubation feeding safer and more standardized, potentially reducing aspiration risk and improving short-term nutritional status.
How similar studies have performed: Swallowing-screen–based feeding protocols such as GUSS have shown benefits in stroke populations, but the GUSS-ICU adaptation for immediate post-extubation ICU patients is relatively new with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Istanbul and 1 other locations
- Bakırköy Dr. Sadi Konuk Training and Research Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
- Istanbul Universitesi-Cerrahpasa — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Merve TURKAY — Istanbul Universitesi-Cerrahpasa
- Study coordinator: Merve TURKAY
- Email: turkay_merve@hotmail.com
- Phone: +905313793706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dysphagia, Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization, DYSPHAGIA, ICU, POST- EXTUBATION