Using a decision support tool to improve ventilation in children with ARDS
A Computerized Decision Support Tool for Ventilator Management in Pediatric Acute Respiratory Distress Syndrome Pilot Study
NA · Children's Hospital Los Angeles · NCT04068012
This study is trying out a new tool to help doctors manage breathing machines better for kids with serious lung problems to see if it can improve their recovery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles (other) |
| Locations | 8 sites (Chicago, Illinois and 7 other locations) |
| Trial ID | NCT04068012 on ClinicalTrials.gov |
What this trial studies
This study aims to implement a Clinical Decision Support (CDS) tool to standardize ventilator management for infants and children suffering from Pediatric Acute Respiratory Distress Syndrome (PARDS). The CDS tool, developed at Children's Hospital Los Angeles, will be deployed across multiple Pediatric Intensive Care Units (PICUs) to enhance adherence to evidence-based practices in mechanical ventilation. The study will assess the feasibility, acceptability, and compliance with the CDS recommendations, targeting improvements in patient outcomes such as reduced time on mechanical ventilation and minimized ventilator-induced injuries. Data will be captured automatically to ensure timely and relevant information is provided to clinicians.
Who should consider this trial
Good fit: Ideal candidates include children over 1 month and under 18 years of age who are on mechanical ventilation for PARDS and meet specific oxygenation criteria.
Not a fit: Patients with conditions that prevent conventional weaning methods or those with severe respiratory complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced complications for children with PARDS requiring mechanical ventilation.
How similar studies have performed: Previous studies have shown success in adult populations using similar decision support tools, indicating potential for positive outcomes in pediatric settings as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children \> 1 month of age and \>44 weeks gestation and ≤ 18 years of age AND * Supported on mechanical ventilation with pulmonary parenchymal disease (i.e. Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5) or Oxygenation Index (OI) ≥ 4 AND * Who are within 72 hours of initiation of invasive mechanical ventilation AND * Who are anticipated to require \>72 hours mechanical ventilation. Exclusion Criteria: * Conditions on enrollment that preclude conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, bronchiolitis, critical airway, Extra Corporeal Life Support (ECLS), intubation for Upper Airway Obstruction, Do Not Resuscitate orders, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR * Conditions precluding the use of permissive hypercapnia or hypoxemia (i.e. intracranial hypertension, severe pulmonary hypertension) * Primary Attending physician refuses to enroll the patient
Where this trial is running
Chicago, Illinois and 7 other locations
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (RECRUITING)
- Riley Hospital for Children — Indianapolis, Indiana, United States (RECRUITING)
- Penn State University — Hershey, Pennsylvania, United States (RECRUITING)
- University of Utah — Salt Lake City, Utah, United States (NOT_YET_RECRUITING)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (RECRUITING)
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)
- CHU Sainte-Justine — Montreal, Quebec, Canada (RECRUITING)
- Ospedale Pediatrico Bambino Gesu — Roma, Italy (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Christopher J Newth, MD — Children's Hospital Los Angeles
- Study coordinator: Christopher J Newth, MD
- Email: cnewth@chla.usc.edu
- Phone: 3233612557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ventilation Therapy, Complications, Ventilator-Induced Lung Injury, Ards