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NCT04068012 · ClinicalTrials.gov registry record · NA
Clinical Decision Support Tool in PARDS Pilot Study
A NA study of ARDS and Ventilation Therapy; Complications, sponsored by Children's Hospital Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 8
- Study locations
NCT04068012 is a NA study of ARDS and Ventilation Therapy; Complications that is actively recruiting participants, run by Children's Hospital Los Angeles. The registered enrollment target is 180 participants, below the 574-participant average among 14 other ARDS trials with a reported enrollment target (69% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT04068012, a NA study of ARDS and Ventilation Therapy; Complications, is actively recruiting participants, sponsored by Children's Hospital Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 574-participant average among 14 other ARDS trials with a reported enrollment target (69% lower). The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with ARDS appearing as the primary indexed condition, and to 1 intervention - of which Ventilator protocol is the first listed.
NCT04068012 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Wisconsin, Illinois, Indiana.
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: ARDS, Ventilation Therapy; Complications, Ventilator-Induced Lung Injury.
What interventions are being tested in trial NCT04068012?
The interventions under investigation include: Ventilator protocol (OTHER).
Who is sponsoring clinical trial NCT04068012?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
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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