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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Respiratory Distress Syndrome; Congenital Heart Disease in Children; Pneumonia in Children; Respiratory Failure (Pediatric Patients)
• Intervention / Treatment: Other: AI-generated recommendations for ventilator parameters.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: AI-Guided Group	Other: AI-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical Ventilation-Related Complications	Cumulative duration of mechanical ventilation, reintubation rate (within 48 hours of extubation), ventilator-associated pneumonia (VAP), barotrauma.	From the start of tracheal intubation to Day 28
Length of Hospital Stay	PICU Length of Stay, Total Hospital Length of Stay	The duration from the time of admission to discharge for pediatric patients-up to a maximum of three months.
Artificial Intelligence System Evaluation	Rate of physician adoption of AI recommendations	From the start of tracheal intubation to Day 28

Collaborators and Investigators

• Sponsor: Wu Rongzhou

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome; Respiratory Insufficiency
• Other Study ID Numbers: 2026-K-301-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No