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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Routine ICU Enteral Nutrition Care: Standard ICU nursing for enteral nutrition without systematic BSFS assessment.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Severity of enteral nutrition-associated diarrhea — 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 — 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).

Trial sites (1)

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