Pediatric Helmet CPAP Pilot Study

Columbia University5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bronchiolitis, Viral Pneumonia, Viral Pneumonia, Bacterial

Interventions

Helmet CPAPDEVICE

Vyatil nonpowered oxygen tent system

Eligibility

Sex: ALLMin age: 1 MonthMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Number of Participants Who Tolerated CPAP Helmet 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.

Time frame: Four hours

Secondary Outcomes

Respiratory Rate

Respiratory rate will be measured in breaths per minute every hour for four hours.

Time frame: 4 hours

Heart Rate

Heart rate will be measured in beats per minute every hour for 4 hours.

Time frame: 4 hours

Oxygen Saturation

Pulse oxygen saturation will be measured as a percent every hour for 4 hours.

Time frame: 4 hours

Systolic Blood Pressure

Systolic blood pressure will be measured in millimeters of mercury every hour for 4 hours.

Time frame: 4 hours

Data from ClinicalTrials.gov

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