Early Rehabilitation Nursing for Severe Acute Pancreatitis

Qiandi Huang

Status: Completed

Conditions: Acute Pancreatitis Drug-Induced

Treatments: Behavioral: Routine Care; Behavioral: Structured Early Rehabilitation Nursing Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT07076316

JHUSH-SAP-ERN-2021-01

Details and patient eligibility

About

This randomized controlled trial evaluates the clinical efficacy of a structured early rehabilitation nursing (ERN) pathway compared to routine care in patients with severe acute pancreatitis (SAP). The study aims to determine if the ERN pathway, which includes phased mobility, respiratory training, and psychological support, can improve gastrointestinal recovery, reduce hospital stay and complications, and enhance functional independence and quality of life.

Full description

Severe acute pancreatitis (SAP) is a life-threatening condition with high mortality and morbidity, often complicated by prolonged immobilization, leading to muscle atrophy, delayed gut recovery, and increased infection risk. Current nursing practices often neglect early mobilization. This study introduced and tested a structured early rehabilitation nursing pathway (SERNP) designed to address these gaps. A total of 104 eligible SAP patients were randomly assigned to either the SERNP group (n=52) or a control group receiving routine care (n=52). The SERNP intervention was initiated within 48 hours of achieving hemodynamic stability and was delivered in three phases over 14 days: Phase 1 (Days 1-3) focused on bedside passive exercises and respiratory training; Phase 2 (Days 4-7) introduced progressive mobilization like sitting and assisted standing; and Phase 3 (Days 8-14) involved supervised ambulation. The study hypothesis was that the SERNP would accelerate recovery and improve outcomes by addressing both the physiological and psychosocial consequences of SAP.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Severe Acute Pancreatitis (SAP) according to the Revised Atlanta Classification.
• APACHE II score > 8.
• Expected ICU stay ≥ 14 days.
• Hemodynamic stability (mean arterial pressure ≥ 65 mmHg for > 24 hours).
• Provided informed consent.

Exclusion criteria

• Presence of chronic metabolic disorders (e.g., end-stage renal disease, cirrhosis).
• Coagulopathy (INR > 1.5 or platelet count < 50×10⁹/L).
• Cognitive impairment hindering cooperation with the rehabilitation protocol.
• Recent use of antiplatelet or anticoagulant medication (within 7 days).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

ERN Group

Experimental group

Description:

Patients received a structured early rehabilitation nursing pathway (SERNP) in addition to routine care. The intervention was implemented within 48 hours of hemodynamic stability and included: * Phase 1 (Days 1-3): Bedside passive range-of-motion exercises (10 min/session, 2x/day), respiratory training (lip pursing and abdominal breathing, 3 sessions/day), and gradual head-of-bed elevation (30° to 90°). * Phase 2 (Days 4-7): Progressive mobilization including sitting at bedside (5-10 min, 3x/day) and assisted standing with a tilt-table (≤15 min/session). * Phase 3 (Days 8-14): Supervised ambulation (2-5 meters, 2x/day) with mobility aids.

Treatment:

Behavioral: Structured Early Rehabilitation Nursing Pathway

Control Group

Active Comparator group

Description:

Patients received routine care, which included vital sign monitoring, strict fasting, fluid balance recording, and passive limb mobilization twice daily.

Treatment:

Behavioral: Routine Care