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Ventilator Protocol for Pediatric Acute Respiratory Distress Syndrome

N/A

Recruiting

Led By Christopher J Newth, MD

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children > 1 month of age and >44 weeks gestation and ≤ 18 years of age 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

Be younger than 65 years old

Must not have

Conditions precluding the use of permissive hypercapnia or hypoxemia (i.e. intracranial hypertension, severe pulmonary hypertension)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a computer program that gives doctors recommendations on how to ventilate children with a certain lung disease. They want to see if the program is usable in different hospitals and if it leads to shorter ventilator use.

Who is the study for?

This trial is for children over 1 month old and under 18 years who need mechanical ventilation due to severe lung problems (PARDS) and are expected to be on a ventilator for more than 72 hours. It's not for patients whose doctors refuse participation or those with conditions that make certain breathing strategies unsafe.

What is being tested?

The study tests a Clinical Decision Support tool designed to help doctors manage ventilators in pediatric ICUs based on the best evidence available. The goal is to see if this tool can standardize care, ensure adherence to recommendations, and potentially shorten time on ventilation.

What are the potential side effects?

Since this trial involves implementing a decision support protocol rather than a drug, there aren't direct side effects like medications have. However, changes in ventilator management could impact patient comfort or respiratory function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is on a ventilator due to severe lung disease and meets the age and oxygenation criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have conditions like severe brain or lung pressure that prevent certain treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first. for reporting.