Clinical Trial

AI-Guided Mechanical Ventilation in Children: A Randomized Controlled Trial

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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.
Trial Details
NCT Number NCT07728136
Lead Sponsor Wu Rongzhou
Conditions Acute Respiratory Distress Syndrome, Pneumonia in Children, Respiratory Failure (Pediatric Patients), Congenital Heart Disease in Children
Enrollment 200 participants
Start Date 2026-09-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-27