Clinical Decision Support Tool in PARDS Pilot Study (NCT04068012)
A Computerized Decision Support Tool for Ventilator Management in Pediatric Acute Respiratory Distress Syndrome Pilot Study
๐ฉบ Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Ann & Robert H. Lurie Children's Hospital of Chicago โ Chicago, Illinois
Age range: 1 Month to 18 Years
๐งช Interventions in This Study
- Ventilator protocol (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (8 Sites)
- Ann & Robert H. Lurie Children's Hospital of Chicago โ Chicago, Illinois
- Riley Hospital for Children โ Indianapolis, Indiana
- Penn State University โ Hershey, Pennsylvania
- University of Utah โ Salt Lake City, Utah
- University of Wisconsin-Madison โ Madison, Wisconsin
- Children's Hospital of Wisconsin โ Milwaukee, Wisconsin
- CHU Sainte-Justine โ Montreal, Quebec
- Ospedale Pediatrico Bambino Gesu โ Roma,
๐ Contact the Study Coordinator
Phone: (323) 361-2557
Email: cnewth@chla.usc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.