Acute Respiratory Distress Syndrome, Congenital Heart Disease in Children, Pneumonia in Children, Respiratory Failure (Pediatric Patients)
Conditions
Brief summary
This prospective, randomized controlled trial aims to evaluate whether an AI-driven 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. 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 compared to those managed with standard care by medical staff? Eligible pediatric patients requiring mechanical ventilation following tracheal intubation will be randomly assigned (1:1) to either the AI-guided intervention group or the standard care control group. In the intervention group, physicians will receive real-time, AI-generated recommendations for ventilator parameters to inform clinical adjustments. In contrast, the control group will be managed according to standard clinical protocols. This study seeks to assess whether AI-driven ventilator optimization can effectively improve clinical outcomes and shorten ventilation duration for pediatric patients in the PICU.
Interventions
OTHERAI-generated recommendations for ventilator parameters.
In the AI-Guided Group, physicians will receive real-time, AI-generated recommendations for ventilator parameters to inform clinical adjustments.
Sponsors
Wu Rongzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
In the intervention group, physicians will receive real-time, AI-generated recommendations for ventilator parameters to inform clinical adjustments. In contrast, the control group will be managed according to standard clinical protocols.
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. PICU patients aged 1 month to 18 years. 2. Receiving invasive mechanical ventilation, expected to last ≥ 24 hours. 3. Informed consent signed before 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 |
|---|---|---|
| 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 | Rate of physician adoption of AI recommendations |
Outcome results
None listed