Bristol Stool Scale-Based Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Ill Patients

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое BSFS-Based Diarrhea Care Pathway
  Standardized nursing pathway: stool assessment every 4 h using the Bristol Stool Form Scale, with graded interventions (monitoring frequency, infusion-rate adjustment, formula change, probiotics, perianal skin protection, stepwise feeding resumption) triggered by stool type 5/6/7. Applied to the Care Pathway Group.
• Другое Routine ICU Enteral Nutrition Care
  Standard ICU nursing for enteral nutrition without systematic BSFS assessment.

Первичные конечные точки

• Severity of enteral nutrition-associated diarrhea [Срок оценки: Daily across the observation period (Day 1 to Day 7)]
• Incidence of ENAD [Срок оценки: Day 1 to Day 7]

Вторичные конечные точки (3)

• Duration of diarrhea [Срок оценки: Day 1 to Day 7]
• Incidence and severity of incontinence-associated dermatitis [Срок оценки: Day 1 to Day 7]
• ICU length of stay [Срок оценки: Through study completion, up to Day 14]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Department of Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University — Сиань

Идентификаторы

NCT: NCT07683364 · K202604-31

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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