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Clinical Decision Support Tool in PARDS Pilot Study
NCT04068012 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER Ventilator protocol
Study Locations (8)
Wisconsin
- University of Wisconsin-Madison — Madison
- Children's Hospital of Wisconsin — Milwaukee
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Indiana
- Riley Hospital for Children — Indianapolis
Pennsylvania
- Penn State University — Hershey
Utah
- University of Utah — Salt Lake City
Quebec
- CHU Sainte-Justine — Montreal
Other
- Ospedale Pediatrico Bambino Gesu — Roma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2025-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04068012
The ClinicalTrials.gov registry entry for NCT04068012 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Ventilation Therapy; Complications appearing as the primary indexed condition, and to 1 intervention — of which Ventilator protocol is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04068012 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Wisconsin, Illinois, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04068012 about?
NCT04068012 is a clinical study titled "Clinical Decision Support Tool in PARDS Pilot Study". 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)...
What is the current status of trial NCT04068012?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2020-12-01. Estimated completion is 2025-07-01.
What conditions does trial NCT04068012 study?
This clinical trial studies the following conditions: Ventilation Therapy; Complications, Ventilator-Induced Lung Injury, Ards. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04068012?
The interventions under investigation include: Ventilator protocol (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04068012?
This trial is sponsored by Children's Hospital Los Angeles, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04068012 being conducted?
This trial has 8 study locations across Illinois, Indiana, Pennsylvania, Utah, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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