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

N/ANot Yet RecruitingNCT07728136

Wu Rongzhou200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

200

Conditions

Acute Respiratory Distress Syndrome Pneumonia in Children

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of ventilator-free days within 28 days

Days survived and free from invasive ventilation

Time frame: From the start of tracheal intubation until 28 days after tracheal intubation.

Secondary Outcomes

Mechanical Ventilation-Related Complications

Cumulative duration of mechanical ventilation, reintubation rate (within 48 hours of extubation), ventilator-associated pneumonia (VAP), barotrauma.

Time frame: From the start of tracheal intubation to Day 28

Length of Hospital Stay

PICU Length of Stay, Total Hospital Length of Stay

Time frame: 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