Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children: A Multi-center, Stratified Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Nurses' Compliance with Feeding Tube Practice Behavior
研究概览
简要总结
This study aims to evaluate the feasibility and effectiveness of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " (T/CNAS 45-2024) in a multicenter setting. Tube feeding is a critical intervention for maintaining the nutritional status of critically ill children, particularly when oral intake of sufficient nutrition is not possible. While there are established guidelines for enteral nutrition in adults, the specific needs of critically ill children have not been sufficiently addressed. This study, based on the "Grol and Wensing Implementation of Change Model" in implementation science, will guide the clinical implementation of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " across multiple centers. The goal is to provide practical evidence for the nationwide application of this standard, enhance the quality of tube feeding care for critically ill children, and ultimately improve clinical outcomes for these patients.
详细描述
Tube feeding is the administration of liquid food, fluids, nutritional preparations, and medications directly into the gastrointestinal tract of a patient through an enteral feeding tube to meet their nutritional and therapeutic needs. In the treatment of critically ill children, tube feeding plays a vital role in maintaining nutritional status and preventing complications such as gastrointestinal failure. However, problems such as tube displacement, aspiration, excessive gastric residual volume, and abdominal distension may occur, increasing the risk of complications and potentially threatening the child's life. Therefore, standardized nursing practices are crucial.
Several enteral nutrition guidelines have been published internationally and domestically, which provide clear recommendations on nutritional assessment, early initiation of enteral nutrition, and ensuring adequate nutritional intake. However, these guidelines mainly focus on adults or nutritional protocols, with insufficient practical guidance on tube feeding care for children, especially critically ill children. To address this gap, the Chinese Nursing Association published the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " (T/CNAS 45-2024) in 2024, providing targeted clinical practice guidelines.
The "Standard" covers essential requirements, feeding preparation, speed control, monitoring during feeding, and post-feeding disposal, offering a standardized feeding process for critically ill children. Research has shown that following standardized processes significantly reduces adverse reactions such as vomiting and aspiration. However, differences in the environment, resources, and management models between healthcare institutions may affect the feasibility and effectiveness of implementing the "Standard" in clinical practice, and further research is needed to identify potential barriers and strategies for implementation.
This study, based on the Grol and Wensing Implementation of Change Model, aims to guide the clinical implementation of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " in multiple centers. The goal is to provide practical evidence for the nationwide adoption of the standard, improve tube feeding care quality, and ultimately enhance clinical outcomes for critically ill children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Nurses who have worked in the Pediatric Intensive Care Unit (PICU) for ≥ 3 months, completed the departmental training, and are capable of independently performing feeding tube procedures.
- •Nurses who hold a valid and legal nursing license.
- •Nurses who voluntarily participate in the study and sign the informed consent form.
排除标准
- •Nurses who are trainees or interns.
- •Nurses who are on leave or not on duty.
- •Pediatric Patients：
- •Critically ill children aged > 28 days and ≤ 18 years.
- •Length of hospital stay ≥ 24 hours.
- •Children receiving nutritional support via feeding tube during hospitalization.
- •Parents or legal guardians of the child have signed the informed consent form, agreeing to the child's participation in the study.
- •Children who are fed via gastrostomy or jejunostomy.
- •Children who are in the transition phase from tube feeding to oral feeding and can partially consume food orally.
研究组 & 干预措施
Evidence-based tube feeding care for critically ill children
This arm will implement the "Standard for Tube Feeding Care of Critically Ill Children" (T/CNAS 45-2024) across multiple centers, monitoring changes in care quality, improving tube feeding practices, and identifying complications in critically ill pediatric patients.
干预措施: Evidence-based tube feeding care (Behavioral)
Routine enteral feeding procedure
Enteral feeding will be conducted according to the existing nursing protocols for enteral nutrition in each participating center.
干预措施: Routine Enteral Feeding Care (Other)
结局指标
主要结局
Nurses' Compliance with Feeding Tube Practice Behavior
时间窗: through study completion，8 months
The total number of feeding tube procedures performed by nurses during the study period will serve as the denominator, while the number of procedures that adhere to best evidence practice guidelines will be the numerator, calculating the compliance rate of nurses' feeding tube practice behavior.
Energy Target Achievement Rate
时间窗: through study completion，8 months
The ratio of the target energy required by the feeding protocol to the actual energy delivered to the patient, calculating the energy target achievement rate.
次要结局
- Adverse Event Rate(through study completion，8 months)
- Nurses' Knowledge Level on Feeding Tube Care(Baseline (first month of the study) and post-intervention (after completing the 7-month intervention))