RECRUITING

Clinical Decision Support Tool in PARDS Pilot Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2020-12-01
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04068012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children \> 1 month of age and \>44 weeks gestation and ≤ 18 years of age AND
  2. * 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
  3. * Who are within 72 hours of initiation of invasive mechanical ventilation AND
  4. * Who are anticipated to require \>72 hours mechanical ventilation.
  1. * 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
  2. * Conditions precluding the use of permissive hypercapnia or hypoxemia (i.e. intracranial hypertension, severe pulmonary hypertension)
  3. * Primary Attending physician refuses to enroll the patient

Contacts and Locations

Study Contact

Christopher J Newth, MD
CONTACT
3233612557
cnewth@chla.usc.edu
Robinder G Khemani, MD
CONTACT
3233612376
rkhemani@chla.usc.edu

Principal Investigator

Christopher J Newth, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
Penn State University
Hershey, Pennsylvania, 17033
United States
University of Utah
Salt Lake City, Utah, 84112
United States
University of Wisconsin-Madison
Madison, Wisconsin, 53715
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Children's Hospital Los Angeles

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-01
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2020-12-01
Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

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