Randomized Controlled Study on Intelligent Optimization of Ventilator Parameters for Pediatric Patients Undergoing Mechanical Ventilation Based on Large Language Models
Sponsor study identifier
interventional
200
0 countries
N/A
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 22, 2026
Actual (reported)July 27, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of ventilator-free days within 28 days
Days survived and free from invasive ventilation
From the start of tracheal intubation until 28 days after tracheal intubation.
Mechanical Ventilation-Related Complications
From the start of tracheal intubation to Day 28
Length of Hospital Stay
The duration from the time of admission to discharge for pediatric patients-up to a maximum of three months.
Artificial Intelligence System Evaluation
From the start of tracheal intubation to Day 28
In the AI-Guided Group, physicians will receive real-time, AI-generated recommendations for ventilator parameters to inform clinical adjustments.
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First Submitted
July 22, 2026
First Posted
July 27, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 27, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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