GUSS-ICU Safe Nutrition Program After Extubation in ICU Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Changes in malnutrition risk scores and findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: On the 1st and 4th days after extubation]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 2 центра

• Bakırköy Dr. Sadi Konuk Training and Research Hospital — Istanbul
• Istanbul Universitesi-Cerrahpasa — Istanbul

Публикации

• 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

Идентификаторы

NCT: NCT07195383 · E-74555795-050.04-1249240

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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