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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTang-Du Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BSFS-Based Diarrhea Care Pathway
  • Routine ICU Enteral Nutrition Care

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators