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Clinical Decision Support Tool in PARDS Pilot Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jul 2025 to Jul 2027
    • Study completion date: Jul 1, 2025 to Jul 1, 2027
    v10
  2. Notable Primary completion date: Jun 1, 2024 to Jul 2025
    • Study completion date: Jun 1, 2025 to Jul 1, 2025
    v9
  3. Minor Primary completion date: Jun 2024 to Jun 1, 2024
    • Study completion date: Jun 2025 to Jun 1, 2025
    v8
  4. Notable Primary completion date: Jun 2022 to Jun 2024
    • Study completion date: Jun 2023 to Jun 2025
    • Site details revised at 2 of 8 sites
    v7
  5. Minor Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Study Status, Contacts/Locations, Referencesv5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 8
    • Start date changed from estimate of Oct 2020 to Dec 1, 2020
    v4
  3. Notable Start date: Apr 2020 to Oct 2020v3
  4. Notable Start date: Nov 2019 to Apr 2020
    • Primary completion date: Dec 2021 to Jun 2022
    • Study completion date: Dec 2022 to Jun 2023
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04068012
Lead Sponsor Children's Hospital Los Angeles
Conditions
(from sponsor)
Ventilation Therapy; Complications, Ventilator-Induced Lung Injury, Ards
Related terms Acute Lung Injury, Ventilator-Induced Lung Injury
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov