Construction and Evaluation of a Bristol Stool Form Scale-Based Nursing Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Ill Patients: A Prospective, Randomized, Controlled, Single-Center Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Severity of enteral nutrition-associated diarrhea
研究概览
简要总结
Enteral nutrition-associated diarrhea (ENAD) is one of the most common gastrointestinal complications in critically ill patients receiving enteral nutrition, with a reported incidence of 22.3%-63.1%. Current management lacks a standardized nursing process and relies on individual nurse experience. This study constructs a standardized nursing care pathway driven by the Bristol Stool Form Scale (BSFS) and evaluates, in a prospective randomized controlled design, whether it reduces the severity of ENAD compared with routine ICU care. Eligible mechanically fed ICU patients are randomized 1:1 to the care-pathway group or the routine-care group, observed for 7 days (D1-D7) with a follow-up assessment on D14. The primary endpoint is the Hart diarrhea score over the observation period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU critically ill patient (APACHE II score ≥15).
- •Receiving enteral nutrition via nasogastric or nasojejunal tube.
- •No diarrhea in the 24 hours before enrollment (stool frequency <3/day or BSFS type <5).
- •Written informed consent provided by the patient or legal representative.
排除标准
- •Known allergy to components of the enteral nutrition formula used.
- •Organic bowel disease such as inflammatory bowel disease or short bowel syndrome.
- •Pre-existing diarrhea at enrollment (≥3 stools/24 h and BSFS type ≥5).
- •Severe hepatic insufficiency.
- •Clostridioides difficile infection or other stool-culture-confirmed infectious diarrhea.
- •Pregnant or lactating women.
- •Currently participating in another clinical study.
- •Any other condition deemed unsuitable by the investigator.
结局指标
主要结局
Severity of enteral nutrition-associated diarrhea
时间窗: Daily across the observation period (Day 1 to Day 7)
Diarrhea severity rated by the Hart scoring method; each stool over 24 h is scored and summed for a daily total; total ≥12 indicates diarrhea. Rated by independent blinded assessors.
Incidence of ENAD
时间窗: Day 1 to Day 7
Proportion meeting the diarrhea definition (Hart ≥12, or ≥3 stools/24 h with BSFS ≥5, or stool ≥500 g/24 h).
次要结局
- Duration of diarrhea(Day 1 to Day 7)
- Incidence and severity of incontinence-associated dermatitis(Day 1 to Day 7)
- ICU length of stay(Through study completion, up to Day 14)