MedTrace Logo

Clinical Decision Support Tool in PARDS Pilot Study

NCT04068012 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-14

No results posted yet for this study

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).

Conditions

  • Ventilation Therapy; Complications
  • Ventilator-Induced Lung Injury
  • Ards

Interventions

OTHER

Ventilator protocol

open loop ventilator management by a computer based protocol

Sponsors & Collaborators

Principal Investigators

  • Christopher J Newth, MD · Children's Hospital Los Angeles

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2027-07-31
Completion
2027-07-01

Countries

  • United States
  • Canada
  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068012 on ClinicalTrials.gov