Health TrialsbyHealthPanel

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

ConditionsAcute Respiratory Distress SyndromePneumonia in ChildrenRespiratory Failure (Pediatric Patients)Congenital Heart Disease in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorWu Rongzhou

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

PICU patients aged 1 month to 18 years.

Receiving invasive mechanical ventilation, expected to last ≥ 24 hours.

Informed consent signed before enrollment.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-generated recommendations for ventilator parameters.

    Other intervention

    In the AI-Guided Group, physicians will receive real-time, AI-generated recommendations for ventilator parameters to inform clinical adjustments.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: AI-Guided GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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.
3

Artificial Intelligence System Evaluation

Rate of physician adoption of AI recommendations

Time frame
From the start of tracheal intubation to Day 28

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wu Rongzhou

Lead sponsor

Wenzhou Medical University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: