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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Pennsylvania
Penn State University
RECRUITING
Hershey
Utah
University of Utah
NOT_YET_RECRUITING
Salt Lake City
Wisconsin
University of Wisconsin-Madison
RECRUITING
Madison
Children's Hospital of Wisconsin
RECRUITING
Milwaukee
Other Locations
Canada
CHU Sainte-Justine
RECRUITING
Montreal
Italy
Ospedale Pediatrico Bambino Gesu
NOT_YET_RECRUITING
Roma
Contact Information
Primary
Christopher J Newth, MD
cnewth@chla.usc.edu
3233612557
Backup
Robinder G Khemani, MD
rkhemani@chla.usc.edu
3233612376
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 180
Treatments
Experimental: Intervention
Ventilator management using the proposed protocol in both acute and weaning phases
Sponsors
Leads: Children's Hospital Los Angeles

This content was sourced from clinicaltrials.gov