NCT07728136Not yet recruiting
AI-Guided Mechanical Ventilation in Children: A Randomized Controlled Trial
Randomized Controlled Study on Intelligent Optimization of Ventilator Parameters for Pediatric Patients Undergoing Mechanical Ventilation Based on Large Language Models
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Wu Rongzhou
- NCT number
- NCT07728136
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Sept 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Expected survival \< 24 hours
- Irreversible brain injury (GCS = 3 + absence of brainstem reflexes)
- Severe congenital cardiopulmonary malformations affecting ventilation assessment
- Pregnancy (must be ruled out in adolescent girls)
- Currently participating in other ventilation intervention trials
- Guardian refusal to participate
Who the study is looking for
- PICU patients aged 1 month to 18 years.
- Receiving invasive mechanical ventilation, expected to last ≥ 24 hours.
- Informed consent signed before enrollment.
Age in the registry: 1 month to 18 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.