Acute Respiratory Distress Syndrome, Pneumonia in Children, Respiratory Failure (Pediatric Patients)
Conditions
Keywords
Multimodal Large Language Model, Pediatric Intensive Care Unit, Ventilator
Brief summary
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of ventilator-free days within 28 days | From the start of tracheal intubation until 28 days after tracheal intubation. | Days survived and free from invasive ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality rate | 28 and 90 days after the initiation of tracheal intubation | All-cause mortality at 28 and 90 days following tracheal intubation |
| Mechanical Ventilation-Related Complications | From the start of tracheal intubation to Day 28 | Cumulative duration of mechanical ventilation, reintubation rate (within 48 hours of extubation), ventilator-associated pneumonia (VAP), barotrauma. |
| Length of Hospital Stay | The duration from the time of admission to discharge for pediatric patients-up to a maximum of three months. | PICU Length of Stay, Total Hospital Length of Stay |
| Artificial Intelligence System Evaluation | From the start of tracheal intubation to Day 28 | Physician Adoption Rates and Outcomes of Cases Involving Discrepancies Between AI Recommendations and Physician Decisions |
| Health Economics | The duration from the time of admission to discharge for pediatric patients-up to a maximum of three months. | PICU Hospitalization Costs |
Countries
China