Actively Recruiting

Phase Not Applicable
Age: 1Month - 18Years
All Genders
NCT04068012

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

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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