Pediatric Helmet CPAP Pilot Study

Pneumonia, Viral Clinical Trial

Official title:

Helmet CPAP for Infants and Pediatric Patients With Acute Respiratory Distress

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04764929
• Other study ID #: AAAT5640
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2021
• Est. completion date: September 2022

Study information

• Verified date: March 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Viral

Intervention

Device:
• Helmet CPAP
Vyatil nonpowered oxygen tent system

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Patrick Wilson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory rate	We will measure respiratory rate in breaths per minute every hour blood pressure every hour for four hours.	Four hours
Secondary	Heart rate	We will measure heart rate in beats per minute every hour	Four hours
Secondary	Oxygen saturation	We will measure pulse oxygen saturation as a percent every hour	Four hours
Secondary	Systolic blood pressure	We will measure systolic blood pressure in millimeters of mercury every hour	Four hours