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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
BSFS-Based Diarrhea Care Pathway
BehavioralStandardized 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
Other interventionStandard ICU nursing for enteral nutrition without systematic BSFS assessment.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Care Pathway GroupExperimental treatment 1 intervention
Group B: Routine Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Severity of enteral nutrition-associated diarrhea
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.
Time frame
Daily across the observation period (Day 1 to Day 7)2
Incidence of ENAD
Proportion meeting the diarrhea definition (Hart ≥12, or ≥3 stools/24 h with BSFS ≥5, or stool ≥500 g/24 h).
Time frame
Day 1 to Day 7Secondary outcomes
1
Duration of diarrhea
Cumulative hours meeting the diarrhea definition.
Time frame
Day 1 to Day 72
Incidence and severity of incontinence-associated dermatitis
Proportion developing IAD and severity grade.
Time frame
Day 1 to Day 73
ICU length of stay
Days in ICU.
Time frame
Through study completion, up to Day 14Sponsors and contacts
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Source ClinicalTrials.gov
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