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

NCT ID: NCT07025941

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-02

Study Completion Date

2024-06-23

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

Group Type OTHER

Standard Critical Care Nursing Protocol

Intervention Type 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

intervention group

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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Standard 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

Intervention Type OTHER

ICU-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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taizhou Hospital of Traditional Chinese Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Peibei zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taizhou Hospital of Traditional Chinese Medicine

Taizhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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20240511

Identifier Type: -

Identifier Source: org_study_id

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