Real-Time Effort Driven Ventilator Management: A Pilot Study.
Justin C Hotz, Dinnel Bornstein, Kristen Kohler...
https://pubmed.ncbi.nlm.nih.gov/32976348Actively Recruiting
Phase Not Applicable
Age: 1Month - 18Years
All Genders
ID04068012
A Computerized Decision Support Tool for Ventilator Management in Pediatric Acute Respiratory Distress Syndrome Pilot Study
Led by Children's Hospital Los Angeles · Updated on 2026-04-14
180
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a computerized Clinical Decision Support (CDS) tool designed to help manage ventilator settings for infants and children with Pediatric Acute Respiratory Distress Syndrome (PARDS). The study aims to implement this web-based tool across multiple Pediatric Intensive Care Units (PICUs) to standardize care according to the best available pediatric evidence and improve outcomes by reducing time on mechanical ventilation. The tool is already in use at a single center and will now be tested in up to 180 children at various sites. The study involves managing patients using the ventilator protocol through all phases of mechanical ventilation, including acute, stable, and weaning phases, with tests for spontaneous breathing and readiness for extubation. The CDS tool will integrate electronic data capture where possible, adapting to each hospital's technology capabilities to provide timely, standardized recommendations. Patients will remain on the protocol while invasively ventilated, up to a maximum of 28 days or until care is limited or death occurs. Participants will be monitored for how feasible it is to implement the CDS tool and how well healthcare providers follow its recommendations. Data will be collected automatically or manually from bedside monitors and electronic records. The main outcomes measured include the ability to implement the tool across sites and adherence to the protocol, all tracked during the ventilation period capped at 28 days. The study also assesses potential barriers to use and acceptance of the tool in routine clinical practice.
CONDITIONS
Brief Title
Clinical Decision Support Tool in PARDS Pilot Study
Who Can Participate
Age: 1Month - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children older than 1 month and older than 44 weeks gestation up to 18 years of age
- Supported on mechanical ventilation with pulmonary parenchymal disease (Pediatric Acute Respiratory Distress Syndrome) with Oxygen Saturation Index (OSI) ≥ 5 or Oxygenation Index (OI) ≥ 4
- Within 72 hours of starting invasive mechanical ventilation
- Anticipated to require more than 72 hours of mechanical ventilation
You will not qualify if you...
- Conditions preventing conventional weaning methods, such as status asthmaticus, severe lower airway obstruction, bronchiolitis, critical airway, extracorporeal life support (ECLS), intubation for upper airway obstruction, do not resuscitate orders, severe chronic respiratory failure, spinal cord injury above lumbar region, or unrepaired/palliated cyanotic heart disease
- Conditions preventing use of permissive hypercapnia or hypoxemia, such as intracranial hypertension or severe pulmonary hypertension
- Primary attending physician refuses to enroll the patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 28 days or until limitation of care or death, whichever comes first.
Participants undergo ventilator management using the computerized decision support tool during the acute, stable, and weaning phases of mechanical ventilation.
Ongoing management while on invasive mechanical ventilation
Trial Site Locations
Total: 8 locations
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Penn State University
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
4
University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
5
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53715
Actively Recruiting
6
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
7
CHU Sainte-Justine
Montreal, Quebec, Canada
Actively Recruiting
8
Ospedale Pediatrico Bambino Gesu
Roma, Italy
Not Yet Recruiting
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Research Team
C
Christopher J Newth, MD
R
Robinder G Khemani, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
A Phase II randomized controlled trial for lung and diaphragm protective ventilation (Real-time Effort Driven VENTilator management).
Robinder G Khemani, Justin C Hotz, Margaret J Klein...
https://pubmed.ncbi.nlm.nih.gov/31740425