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临床试验/NCT07195383
NCT07195383招募中不适用

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

Istanbul University - Cerrahpasa2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
82
试验地点
2
主要终点
Changes in malnutrition risk scores and findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

GUSS-ICU Applied Group

Experimental

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.

干预措施: Nutrion plan based on GUSS-ICU scale (Other)

Routine Follow-up Group

No Intervention

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

结局指标

主要结局

Changes in malnutrition risk scores and findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation

时间窗: 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.

Change in the incidence of aspiration pneumonia in intensive care patients receiving a GUSS-ICU safe nutrition program after extubation

时间窗: On the 1st and 4th days after extubation

The data in the patient follow-up form will be evaluated with the clinician's supervision.

Change in the frequency of GI symptoms in intensive care patients who received a post-extubation GUSS-ICU safe nutrition program

时间窗: 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.

Changes in dehydration findings in intensive care patients who received a GUSS-ICU Safe Nutrition Program after extubation

时间窗: 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.

次要结局

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

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeliha Tülek

Prof.

Istanbul University - Cerrahpasa

研究点 (2)

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