Clinical Decision Support Tool in PARDS Pilot Study

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT04068012
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
1 Month - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Ventilator protocol — OTHER
    open loop ventilator management by a computer based protocol

Study Details

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).

Key Dates

Start date
Dec 1, 2020
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
    Ventilator management using the proposed protocol in both acute and weaning phases

Primary Outcome Measure

Aim 1: Implementation Feasibility [ Time Frame: through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Lazaro Sanchez-Pinto
Riley Hospital for ChildrenIndianapolisIndiana46202
Samer Abu-Sultaneh
Penn State UniversityHersheyPennsylvania17033
Neal Thomas
University of UtahSalt Lake CityUtah84112
Anna Hubbard
University of Wisconsin-MadisonMadisonWisconsin53715
Awni Al-Subu
Children's Hospital of WisconsinMilwaukeeWisconsin53226
Prakadeshwari Rajapreyar

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By research site
Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILRiley Hospital for Children· Indianapolis, INPenn State University· Hershey, PAUniversity of Utah· Salt Lake City, UTUniversity of Wisconsin-Madison· Madison, WIChildren's Hospital of Wisconsin· Milwaukee, WI

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