Clinical Decision Support Tool in PARDS Pilot Study

Recruiting

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

Who can join

1 Month – 18 Years · All sexes

Full eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

About the study

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).

What is being tested

Ventilator protocol (other)

Sponsor: Children's Hospital Los Angeles · Participants: 180 · Started: Dec 1, 2020

Contact the study team

Christopher J Newth, MD · Phone: 3233612557
Robinder G Khemani, MD · Phone: 3233612376

Official record on ClinicalTrials.gov — NCT04068012

Locations in the U.S.

Illinois	Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
Indiana	Riley Hospital for Children, Indianapolis
Pennsylvania	Penn State University, Hershey
Utah	University of Utah, Salt Lake City (Not yet recruiting)
Wisconsin	University of Wisconsin-Madison, Madison Children's Hospital of Wisconsin, Milwaukee

Conditions

Acute Lung Injury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.