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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: Recruiting NA study of ARDS and Ventilation Therapy; Complications, sponsored by Children's Hospital Los Angeles.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The main outcome for Aim 1 is the ability to install the CDS tool in at least 7 of the 9 potential institutions and get data from each of the minimum of 140 patients anticipated to be enrolled. The survey data will be qualitatively assessed for themes related to barriers to implementation and consider this in future refinements of the CDS tool.
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 |
What NCT04068012 shows while recruiting
NCT04068012 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 574-participant average among 14 other ARDS trials with a reported enrollment target (69% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for ARDS
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04068012's enrollment target sits among peer trials
180 9th of 14 higher than 6 of 14 other ARDS trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ARDS trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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