What this study is
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).
What's being tested
- Ventilator protocol
Intervention · OTHER
open loop ventilator management by a computer based protocol
Study details
- Official title
- A Computerized Decision Support Tool for Ventilator Management in Pediatric Acute Respiratory Distress Syndrome Pilot Study
- Sponsor
- Children's Hospital Los Angeles
- Conditions
- Ventilation Therapy; Complications · Ventilator-Induced Lung Injury · Ards
- Enrolling
- 180 people
- Starts
- 2020-12-01
- Est. completion
- 2025-07-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Month – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Children > 1 month of age and >44 weeks gestation and ≤ 18 years of age AND
- Supported on mechanical ventilation with pulmonary parenchymal disease (i.e. Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5) or Oxygenation Index (OI) ≥ 4 AND
- Who are within 72 hours of initiation of invasive mechanical ventilation AND
- Who are anticipated to require >72 hours mechanical ventilation.
You can't join if
- Conditions on enrollment that preclude conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, bronchiolitis, critical airway, Extra Corporeal Life Support (ECLS), intubation for Upper Airway Obstruction, Do Not Resuscitate orders, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR
- Conditions precluding the use of permissive hypercapnia or hypoxemia (i.e. intracranial hypertension, severe pulmonary hypertension)
- Primary Attending physician refuses to enroll the patient
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
8 openAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
- Lazaro Sanchez-Pinto · Contact
RecruitingRiley Hospital for Children
Indianapolis, Indiana, United States
- Samer Abu-Sultaneh · Contact
RecruitingPenn State University
Hershey, Pennsylvania, United States
- Neal Thomas · Contact
RecruitingUniversity of Utah
Salt Lake City, Utah, United States
- Anna Hubbard · Contact
Not yet recruitingUniversity of Wisconsin-Madison
Madison, Wisconsin, United States
- Awni Al-Subu · Contact
RecruitingChildren's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
- Prakadeshwari Rajapreyar · Contact
Recruiting
2 sites outside the US
CHU Sainte-Justine
Montreal, Quebec, Canada
- Philippe Jouvet · Contact
RecruitingOspedale Pediatrico Bambino Gesu
Roma, Italy
- Fabrizio Chiusolo · Contact
Not yet recruiting
Study team
Sponsor
Children's Hospital Los Angeles
Study ID CHLA-19-00085
Principal investigator
Christopher J Newth, MD
Children's Hospital Los Angeles
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.