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Helmet CPAP for Bronchiolitis

N/A
Waitlist Available
Research Sponsored by Patrick Wilson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One month to 5 years of age (inclusive) admitted to the PICU with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask CPAP for at least four hours but less than 48 hours, and parental informed consent.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four hours
Awards & highlights

Study Summary

This study is evaluating whether CPAP through a helmet is the same or better than CPAP through a mask.

Eligible Conditions
  • Bronchiolitis
  • Viral Pneumonia
  • Bacterial Pneumonia

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and four hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tolerability of helmet CPAP
Secondary outcome measures
Heart rate
Oxygen saturation
Respiratory rate
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Helmet CPAPExperimental Treatment1 Intervention
Patients in the Pediatric Intensive Care Unit (PICU) already receiving CPAP through a facemask or nasal prongs or mask for at least four hours but no more than 48 hours will be transitioned to the Vyatil nonpowered oxygen tent system (Rochester, NY) by trained respiratory therapists per the manufacture's instructions: patient's neck circumference will be measured with a soft tape measure to ensure appropriate sizing. The helmet will be connected to at least 30 liters per minute of high flow medical air with an oxygen blender. The expiratory limb will be attached to the positive end expiratory pressure (PEEP) valve (initially set at 5 centimeters of water pressure) connected to a high-efficiency particulate air (HEPA) filter to prevent any viral particles from being released into the environment. A disposable manometer will be used to measure the pressure within the helmet. Once the flow to the helmet interface is on, the helmet will be sealed and secured with the system's arm straps.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Helmet CPAP
2010
N/A
~110

Find a Location

Who is running the clinical trial?

Patrick WilsonLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pediatric Helmet CPAP Pilot Study
Patrick Wilson 2021. "Pediatric Helmet CPAP Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04764929.
~8 spots leftby Apr 2025
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