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/Actively Recruiting
Led by Children's Hospital Los Angeles · Updated on 2026-04-14
180
Participants Needed
8
Research Sites
N/A
Total Duration
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 hospitals 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
Clinical Decision Support Tool in PARDS Pilot Study
C
Christopher J Newth, MD
R
Robinder G Khemani, MD
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Children's Hospital Los Angeles
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Computer-based Ventilator Management | Current Practice: Guideline-based Ventilator Management |
|---|---|---|
| What it is | A computer-based clinical decision support tool that provides protocolized ventilator management recommendations for children with PARDS. Clinicians use the tool’s advice alongside clinical judgment when adjusting ventilation settings. | Clinician-managed mechanical ventilation for PARDS guided by consensus recommendations (PALICC), including lung-protective strategies such as low tidal volumes, PEEP optimization, and adjustment based on disease severity. |
| Role in trial | This is the sole interventional protocol exposed to trial participants. It is being pilot tested for feasibility and implementation in eligible children. | Serves as the established standard-of-care comparator for children with PARDS outside clinical trials. |
| Primary use or goal | To assess whether a computer-guided protocol can be feasibly implemented and adhered to in clinical ventilation management for children with PARDS. | To provide lung-protective mechanical ventilation based on current evidence and consensus to minimize ventilator-induced lung injury in children with PARDS. |
| How it is performed | The clinical decision support tool generates recommendations for ventilator settings based on patient data, but the bedside clinician retains final decision-making authority. | Treating clinicians apply PALICC guideline-recommended strategies, including initial ventilator settings, ongoing adjustments based on oxygenation and clinical response, and protocols for weaning. |
| Evidence status | Still under investigation; no published outcomes yet for this specific computer-guided protocol in the trial population. | Current guideline-based approaches are standard practice for PARDS but are based on limited high-quality pediatric evidence. Adult ARDS evidence and expert consensus strongly influence recommendations. |
| Important limitations | Feasibility and protocol adherence are the primary study outcomes; this trial does not provide direct evidence on patient-level outcomes such as duration of ventilation or survival. The protocol has yet to be validated outside the research setting. | Current guideline recommendations are based in part on neonatal and adult ARDS studies and expert consensus. High-quality pediatric-specific evidence remains limited, so treatment decisions may vary among experienced clinicians. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Robinder G Khemani, Justin C Hotz, Margaret J Klein...
https://pubmed.ncbi.nlm.nih.gov/31740425/Justin C Hotz, Dinnel Bornstein, Kristen Kohler...
https://pubmed.ncbi.nlm.nih.gov/32976348/Children's Hospital Los Angeles
Lead Sponsor