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Recruiting NCT07195383

GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients

No phase Interventional Dysphagia Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nutrion plan based on GUSS-ICU scale.
Who it may be relevant to
Registry conditions: Dysphagia, Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Nutrion 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.

Primary outcome measures

  • 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 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]
  • 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]
  • 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]
Secondary outcome measures (4)
  • Change in Modified Nutrition Risk in the Critically Ill (m-NUTRIC) score [Time frame: On the 1st and 4th days after extubation]
  • Change in APACHE II score [Time frame: On the 1st and 4th days after extubation]
  • Change in SOFA (Sequential Organ Failure Assessment) Score [Time frame: On the 1st and 4th days after extubation]
  • Change in Scored Patient-Generated Subjective Global Assessment (PG-SGA) score [Time frame: On the 1st and 4th days after extubation]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 2 centers
  • Bakırköy Dr. Sadi Konuk Training and Research Hospital — Istanbul
  • Istanbul Universitesi-Cerrahpasa — Istanbul

Publications

  • Troll C, Trapl-Grundschober M, Teuschl Y, Cerrito A, Compte MG, Siegemund M. A bedside swallowing screen for the identification of post-extubation dysphagia on the intensive care unit - validation of the Gugging Swallowing Screen (GUSS)-ICU. BMC Anesthesiol. 2023 Apr 13;23(1):122. doi: 10.1186/s12871-023-02072-6. PMID 37055724

Identifiers

NCT: NCT07195383 · E-74555795-050.04-1249240

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗