Using Artificial Intelligence To Improve Ventilator Settings For Intensive Care Patients

N/ACompletedNCT07592039

Wu Rongzhou2,000 enrolled

Overview

This observational study aims to determine whether an AI-assisted decision support system can improve clinical outcomes for mechanically ventilated pediatric patients (aged 1 month to 18 years) in the PICU, compared to standard care provided by medical staff. The primary question addressed is: Do patients whose ventilator parameter optimization decisions are guided by AI assistance achieve a greater number of ventilator-free days within 28 days than those managed by medical staff? By utilizing clinical data collected following tracheal intubation to generate AI-driven recommendations-and comparing these against the actual adjustments made by physicians-this study seeks to assess whether the AI-assisted decision support system can effectively improve clinical outcomes for mechanically ventilated patients in the PICU.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Acute Respiratory Distress Syndrome Pneumonia in Children Respiratory Failure (Pediatric Patients)

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. PICU patients aged 1 month to 18 years. 2. Receiving invasive mechanical ventilation, expected to last ≥ 48 hours. 3. Informed consent signed prior to enrollment. Exclusion Criteria: 1. Expected survival \< 24 hours 2. Irreversible brain injury (GCS = 3 + absence of brainstem reflexes) 3. Severe congenital cardiopulmonary malformations affecting ventilation assessment 4. Pregnancy (must be ruled out in adolescent girls) 5. Currently participating in other ventilation intervention trials 6. Guardian refusal to participate

Outcomes

Primary Outcomes

Number of ventilator-free days within 28 days

Days survived and free from invasive ventilation

Time frame: From the start of tracheal intubation until 28 days after tracheal intubation.

Secondary Outcomes

mortality rate

All-cause mortality at 28 and 90 days following tracheal intubation

Time frame: 28 and 90 days after the initiation of tracheal intubation

Mechanical Ventilation-Related Complications

Cumulative duration of mechanical ventilation, reintubation rate (within 48 hours of extubation), ventilator-associated pneumonia (VAP), barotrauma.

Time frame: From the start of tracheal intubation to Day 28

Length of Hospital Stay

PICU Length of Stay, Total Hospital Length of Stay

Time frame: The duration from the time of admission to discharge for pediatric patients-up to a maximum of three months.

Artificial Intelligence System Evaluation

Physician Adoption Rates and Outcomes of Cases Involving Discrepancies Between AI Recommendations and Physician Decisions