FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS: A PROSPECTİVE OBSERVATİONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 主要终点
- Occurrence of Enteral Feeding Intolerance
研究概览
简要总结
Enteral nutrition is the first-line nutritional support method in critically ill patients because it helps preserve gastrointestinal system integrity, reduce the risk of infection, and meet metabolic requirements. However, gastrointestinal motility is frequently impaired in critically ill patients due to physiological stress, hemodynamic instability, sedative and vasopressor medications, mechanical ventilation, and underlying diseases. This may result in enteral feeding intolerance (EFI), which complicates nutritional management.
This prospective observational study aims to determine the demographic, clinical, laboratory, and treatment-related factors associated with enteral feeding intolerance in adult intensive care unit patients and to evaluate the association between enteral feeding intolerance and morbidity and mortality.
Adult patients who are started on enteral nutrition in the Anesthesiology and Reanimation Intensive Care Unit will be prospectively followed. No additional intervention will be performed. Patients will be monitored according to routine intensive care and enteral nutrition protocols. Enteral feeding intolerance and potentially associated factors will be recorded prospectively.
The study is planned to include 102 patients.
详细描述
Enteral nutrition is an important component of nutritional support in critically ill patients. However, enteral feeding intolerance is frequently observed in intensive care units and may result from impaired gastrointestinal motility associated with critical illness, hemodynamic instability, sedative and vasopressor use, mechanical ventilation, and underlying diseases.
In this study, demographic, clinical, laboratory, physiological, nutritional, and treatment-related variables that may affect the development of enteral feeding intolerance will be evaluated prospectively.
All adult patients admitted to the intensive care unit who are planned to receive enteral nutrition will be screened daily. Patients meeting the eligibility criteria will be enrolled after informed consent has been obtained from the patient or legally authorized representative.
Because this is an observational study, there will be no randomization and no investigator-assigned intervention. Patients will be classified according to their natural clinical course into an enteral feeding intolerance group and a non-enteral feeding intolerance group.
Demographic characteristics, admission diagnosis, APACHE II, SOFA, and Glasgow Coma Scale scores will be recorded. Daily clinical variables including bowel sounds, presence of stool, sedation, opioid use, vasopressor requirement, sepsis, and aspiration pneumonia will also be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 years
- •Admission to the Anesthesia Intensive Care Unit
- •Enteral nutrition planned or initiated during intensive care unit admission
- •Expected to require enteral nutrition during intensive care unit follow-up
- •Availability of sufficient clinical and nutritional data for study evaluation
- •Patient or legally authorized representative provides informed consent when required by the ethics protocol
排除标准
- •Age <18 years
- •Patients receiving only parenteral nutrition
- •Patients in whom enteral nutrition is contraindicated throughout the observation period
- •Patients with insufficient data for evaluation of enteral feeding tolerance
- •Patients transferred to another intensive care unit before adequate study assessment
- •Patients who decline participation or whose legally authorized representative declines participation when consent is required
结局指标
主要结局
Occurrence of Enteral Feeding Intolerance
时间窗: 7 days
Enteral feeding intolerance will be defined by the presence of at least one predefined clinical criterion: vomiting, a single gastric residual volume greater than 250 mL, 24-hour cumulative gastric residual volume greater than 500 mL, abdominal distension, or clinical suspicion of aspiration related to enteral feeding.
次要结局
- Achievement of Energy Target(3 days)
研究者
Eda Cirit Bardakçi
Medical Doctor
Ankara Ataturk Sanatorium Training and Research Hospital