RecruitingNot ApplicableNCT04068012

Clinical Decision Support Tool in PARDS Pilot Study

A Computerized Decision Support Tool for Ventilator Management in Pediatric Acute Respiratory Distress Syndrome Pilot Study


Sponsor

Children's Hospital Los Angeles

Enrollment

180 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

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 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).


Eligibility

Min Age: 1 MonthMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study tests a computerised clinical decision support tool designed to help doctors manage children with a serious breathing condition called Pediatric Acute Respiratory Distress Syndrome (PARDS). When a child has PARDS, their lungs are severely inflamed and they need help breathing through a ventilator. Adjusting ventilator settings is complex, and the decision support tool is designed to guide doctors toward safer and more consistent ventilator management. The study is observational for now — it looks at whether doctors use the tool's recommendations and what happens to patients. Eventually, such tools could help standardise care and improve outcomes for critically ill children. This study is the important first step to see how the tool works in a real clinical setting. You may be eligible if: - Your child is older than 1 month (and at least 44 weeks gestational age) and under 18 years old - Your child has PARDS and is on a mechanical ventilator - Your child was put on the ventilator within the past 72 hours - Your child is expected to need the ventilator for more than 72 hours You may NOT be eligible if: - Your child has conditions preventing standard ventilator weaning (e.g., severe asthma, ECLS support, spinal cord injury, cyanotic heart disease) - Your child's doctor refuses to enrol them - Your child has conditions making high CO2 or low oxygen unsafe (e.g., raised brain pressure, severe pulmonary hypertension) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERVentilator protocol

open loop ventilator management by a computer based protocol


Locations(8)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Penn State University

Hershey, Pennsylvania, United States

University of Utah

Salt Lake City, Utah, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

CHU Sainte-Justine

Montreal, Quebec, Canada

Ospedale Pediatrico Bambino Gesu

Roma, Italy

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NCT04068012


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