Bristol Stool Scale-Based Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BSFS-Based Diarrhea Care Pathway, Routine ICU Enteral Nutrition Care.
- Who it may be relevant to
- Registry conditions: Critical Illness, Diarrhea. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Behavioral 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. - Other Routine ICU Enteral Nutrition Care
Standard ICU nursing for enteral nutrition without systematic BSFS assessment.
Primary outcome measures
- Severity of enteral nutrition-associated diarrhea [Time frame: Daily across the observation period (Day 1 to Day 7)]
- Incidence of ENAD [Time frame: Day 1 to Day 7]
Secondary outcome measures (3)
- Duration of diarrhea [Time frame: Day 1 to Day 7]
- Incidence and severity of incontinence-associated dermatitis [Time frame: Day 1 to Day 7]
- ICU length of stay [Time frame: Through study completion, up to Day 14]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Department of Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University — Xi'an
Identifiers
NCT: NCT07683364 · K202604-31