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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care Pathway Group | Experimental |
| |
| Routine Care Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BSFS-Based Diarrhea Care Pathway | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily across the observation period (Day 1 to Day 7) |
| Incidence of ENAD | Proportion meeting the diarrhea definition (Hart ≥12, or ≥3 stools/24 h with BSFS ≥5, or stool ≥500 g/24 h). | Day 1 to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of diarrhea | Cumulative hours meeting the diarrhea definition. | Day 1 to Day 7 |
| Incidence and severity of incontinence-associated dermatitis | Proportion developing IAD and severity grade. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Li | Contact | +86 158 0928 5776 | lilu455699299@163.com | |
| Shuai Qiao | Contact | +86 13598089070 | 1255095003@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
De-identified individual participant data underlying the primary study results will be made available beginning 6 months after publication of the main findings. Data will be available to researchers whose proposed use has been reviewed and approved by the study team; requests should be directed to the principal investigator.
Beginning 6 months after publication of the main study results.
Available to researchers upon reasonable request to the principal investigator, following review and approval of the proposal by the study team.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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|
| Routine ICU Enteral Nutrition Care | Other | Standard ICU nursing for enteral nutrition without systematic BSFS assessment. |
|
| Day 1 to Day 7 |
| ICU length of stay | Days in ICU. | Through study completion, up to Day 14 |
| D012816 | Signs and Symptoms |