Actively Recruiting
Clinical Decision Support Tool in PARDS Pilot Study
Led by Children's Hospital Los Angeles · Updated on 2026-04-14
180
Participants Needed
8
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 on mechanical ventilation. This study seeks to scale an established Clinical Decision Support (CDS) tool to facilitate dissemination and implementation of evidence-based research in mechanical ventilation of infants and children with pediatric ARDS (PARDS). This will be accomplished by using CDS tools developed and deployed in Children's Hospital Los Angeles (CHLA) which are based on the best available pediatric evidence, and are currently being used in an NHLBI funded single center randomized controlled trial (NCT03266016, PI: Khemani). Without CDS, there is significant variability in ventilator management of PARDS patients both between and within Pediatric ICUs (PICUs), but clinicians are willing to accept CDS recommendations. The CDS tool will be deployed in multiple PICUs, targeting enrollment of up to 180 children with PARDS. Study hypotheses: 1. The CDS tool in will be implementable in nearly all participating sites 2. There will be \> 80% compliance with CDS recommendations and 3. The investigators can implement automatic data capture and entry in many of the ICUs Once feasibility of this CDS tool is demonstrated, a multi-center validation study will be designed, which seeks to determine whether the CDS can result in a significant reduction in length of mechanical ventilation (LMV).
CONDITIONS
Official Title
Clinical Decision Support Tool in PARDS Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children older than 1 month of age and over 44 weeks gestation and up to 18 years of age
- Supported on mechanical ventilation with pulmonary parenchymal disease (Pediatric Acute Respiratory Distress Syndrome) with Oxygen Saturation Index (OSI) ≥ 5 or Oxygenation Index (OI) ≥ 4
- Within 72 hours of starting invasive mechanical ventilation
- Expected to require more than 72 hours of mechanical ventilation
You will not qualify if you...
- Conditions that prevent usual ventilator weaning methods, such as status asthmaticus, severe lower airway obstruction, bronchiolitis, critical airway, extracorporeal life support, intubation for upper airway obstruction, do not resuscitate orders, severe chronic respiratory failure, spinal cord injury above lumbar region, or unrepaired/palliated cyanotic heart disease
- Conditions preventing use of permissive hypercapnia or hypoxemia, such as intracranial hypertension or severe pulmonary hypertension
- Primary attending physician refuses to enroll the patient
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Penn State University
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
4
University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
5
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53715
Actively Recruiting
6
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
7
CHU Sainte-Justine
Montreal, Quebec, Canada
Actively Recruiting
8
Ospedale Pediatrico Bambino Gesu
Roma, Italy
Not Yet Recruiting
Research Team
C
Christopher J Newth, MD
CONTACT
R
Robinder G Khemani, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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