GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients

NCT ID: NCT07195383

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-05

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GUSS-ICU Applied Group

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.

Group Type EXPERIMENTAL

Nutrion plan based on GUSS-ICU scale

Intervention Type 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.

Routine Follow-up Group

Routine care and follow-up will be applied to the randomly selected control group for 4 days after extubation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Use of the GUSS-ICU scale after extubation

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Zeliha Tülek

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve TURKAY

Role: PRINCIPAL_INVESTIGATOR

Istanbul Universitesi-Cerrahpasa

Zeliha TÜLEK

Role: STUDY_DIRECTOR

Istanbul Universitesi-Cerrahpasa

Locations

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Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul Universitesi-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Merve TURKAY

Role: CONTACT

+905313793706

Zeliha TÜLEK

Role: CONTACT

+905327762993

Facility Contacts

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Role: primary

+90(212) 414 71 71

References

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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.

Reference Type BACKGROUND
PMID: 10099025 (View on PubMed)

Other Identifiers

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E-74555795-050.04-1249240

Identifier Type: -

Identifier Source: org_study_id

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