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NCT Number: NCT07025941

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

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

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Key information

Conditions

Critically Ill Patients Acute Kidney Injury Acute Kidney Injury (AKI) Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Bleeding Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Kidney Diseases Male Urogenital Diseases Nutritional Support Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Infections Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taizhou Hospital of Traditional Chinese Medicine

Taizhou, Jiangsu, 225300, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. ICU Length of Stay (LOS)

    Time frame: From randomization to ICU discharge, up to 60 days

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

Secondary outcomes

  1. Incidence of Pulmonary Infections

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

    Rate 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 outcomes

  1. Protocol Adherence Rate

    Time frame: Daily during 14-day intervention

    Percentage completion of scheduled:

    • Rehabilitation sessions (≥80% sessions completed)
    • Airway care procedures (per protocol)
    • Nutritional targets (≥90% calorie/protein goals)

Sponsors and collaborators

Lead sponsor

Taizhou Hospital of Traditional Chinese Medicine

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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