Impact of Comprehensive Rehabilitation Nursing Combined With Refined Airway Management and Nutritional Support on Prognosis and Care Delivery Models in Critically Ill Patients

NCT07025941 | Completed

• 1 other identifier: 20240511
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This combined intervention protocol effectively improves the prognosis of critically ill patients and optimizes nursing management models

Conditions

Critically Ill Patients; Nutritional Support; Pulmonary Infections; Gastrointestinal Bleeding; Acute Kidney Injury (AKI)

Outcome Measures

Primary Outcomes (1)

• ICU Length of Stay (LOS)

  Calendar days from ICU admission to discharge criteria met (APACHE II score ≤10, hemodynamic stability for ≥24h).

  From randomization to ICU discharge, up to 60 days

Secondary Outcomes (1)

• Incidence of Pulmonary Infections

  From ICU admission to 48 hours post-extubation or 14-day intervention period

Other Outcomes (1)

• Protocol Adherence Rate

  Daily during 14-day intervention

Study Arms (2)

control group

OTHER

Other: Standard Critical Care Nursing Protocol

intervention group

EXPERIMENTAL

Behavioral: ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes)

Interventions

Standard Critical Care Nursing Protocol OTHER

The Standard Critical Care Nursing Protocol encompasses evidence-based, routine nursing practices for critically ill patients in the intensive care unit (ICU). This protocol serves as the control intervention in comparative studies evaluating novel nursing strategies. Key Components: Basic Physiological Monitoring: Continuous assessment of vital signs (heart rate, blood pressure, respiratory rate, SpO₂). Strict intake/output monitoring and electrolyte balance management. Airway Management: Standard oxygen therapy (nasal cannula, face mask) or mechanical ventilation as prescribed. Scheduled suctioning, positional changes, and oral care (every 4-6 hours). Infection Prevention: Aseptic techniques for invasive procedures (e.g., central line care, urinary catheter management). Ventilator-associated pneumonia (VAP) bundle compliance (e.g., head-of-bed elevation, sedation vacations). Mobility \& Skin Integrity: Passive range-of-motion exercises for immobilized patients (2×/day). Pr

control group

ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes) BEHAVIORAL

The intervention group received a standardized 14-day nursing protocol combining three evidence-based components: Comprehensive Rehabilitation Nursing: Early mobilization protocol with passive/active exercises (3-4 sessions/day) Respiratory training using incentive spirometry (Triflo II® devices) Swallowing rehabilitation with VitalStim® electrical stimulation Refined Airway Management: Humidification via Fisher \& Paykel® MR850 systems (33-44 mg/L) Closed suction systems (Ballard® Trach Care) with strict aseptic technique Oral care with 0.12% chlorhexidine solution (Peridex®) 4×/day Nutritional Support: Enteral feeding using Abbott Nutrition® formulas Parenteral nutrition via Baxter®/Fresenius Kabi® solutions Gastric residual monitoring with Kangaroo™ feeding pumps Key Features: Implemented by specialized ICU nurses, respiratory therapists, and dietitians Daily monitoring using Philips® IntelliVue patient monitors Protocol adjustments based on weekly APACHE II scoring

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfillment of ICU admission standards with critical illness confirmed by attending physicians or senior specialists
• Age ≥ 18 years
• Stable vital signs:
• Systolic blood pressure ≥ 90 mmHg and ≤ 180 mmHg
• Heart rate ≤ 120 beats/min
• Oxygen saturation (SpO₂) ≥ 85% under ≤ 60% fraction of inspired oxygen (FiO₂)
• Intact or tolerable gastrointestinal (GI) function for enteral nutrition

You may not qualify if:

• Terminal malignancies
• Brain death
• Irreversible organ failure (e.g., end-stage cirrhosis, advanced heart failure)
• Comorbidities potentially confounding study outcomes
• Contraindications to interventions (e.g., laryngeal edema, complete intestinal obstruction)
• Pregnancy or lactation

Sponsors & Collaborators

• Taizhou Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Taizhou Hospital of Traditional Chinese Medicine

Taizhou, Jiangsu, 225300, China

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 18, 2025
• Study Start: June 2, 2023
• Primary Completion: June 5, 2024
• Study Completion: June 23, 2024
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

CN (1)