Pediatric Helmet CPAP Pilot Study

Study Overview
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Brief Summary
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This a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPAP can help kids with lung infections breathe easier. The machine delivers pressurized air, which may help people with lung infections breathe more easily. Doctors routinely use a Facemask, Nasal Mask or Nasal Prongs to give CPAP for kids with lung infections, but the researchers want to know whether using Helmet CPAP is the same or better.

Detailed Description
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Prior clinical trials have demonstrated efficacy of Helmet CPAP in adults with acute respiratory distress syndrome, superior tolerance and improved respiratory scores compared to nasal/facial CPAP in infants, and no major safety concerns were identified with the use of helmet CPAP. This is a prospective pilot study to (1) determine if infants and pediatric patients requiring CPAP in the PICU will tolerate helmet CPAP for at least four hours, and (2) measure changes in the respiratory rate, oxygen saturation, heart rate and blood pressure over four hours. If helmet CPAP is found to be well tolerated in this small cohort, a larger study comparing it directly to other CPAP interfaces will be conducted.

Official Title
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Helmet CPAP for Infants and Pediatric Patients With Acute Respiratory Distress

Conditions
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Pneumonia, Viral, Bronchiolitis, Viral, Pneumonia, Bacterial

Intervention / Treatment
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* Device: Helmet CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Age less than 1 month or greater than 5 years Positive for COVID-19 Need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (BPAP) Unresponsiveness (GCS 8 or less) Hypotension as defined as a systolic blood pressure less than 5th percentile for age Existing head or neck trauma, known or suspected air leak syndrome (pneumothorax, pneumomediastinum, subcutaneous emphysema), known or suspected increased intracranial pressure Non-English speaking parent

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helmet CPAP<br>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. | Device: Helmet CPAP<br>* Vyatil nonpowered oxygen tent system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of helmet CPAP | Percentage of patients that tolerate helmet CPAP for at least four hours. Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (>5 minutes) removals or disruptions. | Four hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate | We will measure respiratory rate in breaths per minute every hour blood pressure every hour for four hours. | Four hours | 
| Heart rate | We will measure heart rate in beats per minute every hour | Four hours | 
| Oxygen saturation | We will measure pulse oxygen saturation as a percent every hour | Four hours | 
| Systolic blood pressure | We will measure systolic blood pressure in millimeters of mercury every hour | Four hours |