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OpenTrials
Completed

NCT Number: NCT07592039

Using Artificial Intelligence To Improve Ventilator Settings For Intensive Care Patients

This observational study aims to determine whether an AI-assisted 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 provided by medical staff. 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 than those managed by medical staff? By utilizing clinical data collected following tracheal intubation to generate AI-driven recommendations-and comparing these against the actual adjustments made by physicians-this study seeks to assess whether the AI-assisted decision support system can effectively improve clinical outcomes for mechanically ventilated patients in the PICU.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Pneumonia in Children Respiration Disorders Respiratory Distress Syndrome Respiratory Failure (Pediatric Patients) Respiratory Insufficiency Respiratory Tract Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Wenzhou Medical University and Yuying Children's Hospital

Wenzhou, Zhejiang, 325000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PICU patients aged 1 month to 18 years.
  • Receiving invasive mechanical ventilation, expected to last ≥ 48 hours.
  • Informed consent signed prior to enrollment.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Number of ventilator-free days within 28 days

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

    Days survived and free from invasive ventilation

Secondary outcomes

  1. mortality rate

    Time frame: 28 and 90 days after the initiation of tracheal intubation

    All-cause mortality at 28 and 90 days following tracheal intubation

  2. Mechanical Ventilation-Related Complications

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

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

  3. Length of Hospital Stay

    Time frame: The duration from the time of admission to discharge for pediatric patients-up to a maximum of three months.

    PICU Length of Stay, Total Hospital Length of Stay

  4. Artificial Intelligence System Evaluation

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

    Physician Adoption Rates and Outcomes of Cases Involving Discrepancies Between AI Recommendations and Physician Decisions

  5. Health Economics

    Time frame: The duration from the time of admission to discharge for pediatric patients-up to a maximum of three months.

    PICU Hospitalization Costs

Sponsors and collaborators

Lead sponsor

Wu Rongzhou

Other

Registry information

Official study title

Research on Intelligent Optimization of Ventilator Parameters for Intensive Care Patients Based on Multimodal Large Models

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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