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NCT Number: NCT07195383

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakırköy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Use of the GUSS-ICU scale after extubation

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

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

    Time frame: On the 1st and 4th days after extubation

    It will be assessed with the Modified Nutrition Risk in the Critically Ill (m-NUTRIC) score.

  2. Change in APACHE II score

    Time frame: On the 1st and 4th days after extubation

    The effects on mortality will be evaluated with the APACHE II score.

  3. Change in SOFA (Sequential Organ Failure Assessment) Score

    Time frame: On the 1st and 4th days after extubation

    SOFA (Sequential Organ Failure Assessment) Score will be evaluated to determine the effects on mortality.

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

    Time frame: On the 1st and 4th days after extubation

    Possible effects on nutrition will be evaluated using the Scored Patient-Generated Subjective Global Assessment (PG-SGA).

Other outcomes

  1. Change in the number of days from tube feeding to oral feeding

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

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

  2. Change in oral intake (calorie)

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

    Change in oral intake (calorie)

Study contacts

Contact information is provided by the study sponsor or research team.

Merve TURKAY

CONTACT

[email protected]

+905313793706

Zeliha TÜLEK

CONTACT

[email protected]

+905327762993

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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