Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

GUSS-ICU safe nutrition plan for patients after extubation

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

Run by Istanbul University - Cerrahpasa · NCT07195383 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment82 (estimated)
SponsorIstanbul University - Cerrahpasa
Academic / other
Locations2 sites (Istanbul and 1 other locations)
StatusRecruiting
StartedMarch 5, 2025
Main results expectedMarch 5, 2026
Study endsJune 30, 2026
Registry record updatedSeptember 26, 2025
Trial IDNCT07195383 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Bakırköy Dr. Sadi Konuk Training and Research Hospital
    Istanbul, Turkey (Türkiye)
    Recruiting
  • Istanbul Universitesi-Cerrahpasa
    Istanbul, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.