Status:
RECRUITING
Clinical Decision Support Tool in PARDS Pilot Study
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Ventilation Therapy; Complications
Ventilator-Induced Lung Injury
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
Previous clinical trials in adults with acute respiratory distress syndrome (ARDS) have demonstrated that ventilator management choices can improve Intensive Care Unit (ICU) mortality and shorten time...
Detailed Description
The central hypothesis is that CDS will help standardize ventilator management consistent with evidence-based recommendations leading to shorter LMV by limiting VILI (Ventilator Induced Lung Injury), ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04068012
Start Date
December 1 2020
End Date
July 1 2025
Last Update
October 30 2024
Active Locations (8)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
3
Penn State University
Hershey, Pennsylvania, United States, 17033
4
University of Utah
Salt Lake City, Utah, United States, 84112