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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07025941
Enrollment
101
Registered
2025-06-18
Start date
2023-06-02
Completion date
2024-06-23
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

To investigate the impact of comprehensive rehabilitation nursing combined with refined airway management and nutritional support on the prognosis of critically ill patients and nursing management models, and to develop a new care management protocol. Critically ill patients were divided into a control group (routine nursing) and an intervention group (comprehensive rehabilitation nursing combined with refined airway management and nutritional support). Complications such as pulmonary infection and gastrointestinal bleeding, as well as clinical indicators including oxygen saturation (SpO₂), mechanical ventilation time (MVT), and length of stay (LOS), were compared between the two groups. Logistic regression and XGBoost models were constructed to analyze key influencing factors.

Interventions

OTHERStandard Critical Care Nursing Protocol

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

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

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

Sponsors

Taizhou Hospital of Traditional Chinese Medicine
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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 * Informed consent from both patients and families

Exclusion criteria

(1) * 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

Design outcomes

Primary

MeasureTime frameDescription
ICU Length of Stay (LOS)From randomization to ICU discharge, up to 60 daysCalendar days from ICU admission to discharge criteria met (APACHE II score ≤10, hemodynamic stability for ≥24h).

Secondary

MeasureTime frameDescription
Incidence of Pulmonary InfectionsFrom ICU admission to 48 hours post-extubation or 14-day intervention periodRate of ventilator-associated pneumonia (VAP) and other pulmonary infections confirmed by clinical criteria (temperature \>38°C or \<36°C, purulent secretions, leukocytosis \>10×10⁹/L or leukopenia \<4×10⁹/L) plus microbiological evidence from sputum/BALF cultures.

Other

MeasureTime frameDescription
Protocol Adherence RateDaily during 14-day interventionPercentage completion of scheduled: 1. Rehabilitation sessions (≥80% sessions completed) 2. Airway care procedures (per protocol) 3. Nutritional targets (≥90% calorie/protein goals)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026