Pediatric Helmet CPAP Pilot Study

Not Applicable

Terminated

• Conditions: Pneumonia, Bacterial; Pneumonia, Viral; Bronchiolitis, Viral

• Registration Number: NCT04764929
• Lead Sponsor: Columbia University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-08-07
• Primary Completion: 2022-05-19
• Study Completion: 2023-06-14
• Results First Submitted: 2024-05-21
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Results First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours	Four hours	Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (\>5 minutes) removals or disruptions.

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation	4 hours	Pulse oxygen saturation will be measured as a percent every hour for 4 hours.
Respiratory Rate	4 hours	Respiratory rate will be measured in breaths per minute every hour for four hours.
Heart Rate	4 hours	Heart rate will be measured in beats per minute every hour for 4 hours.
Systolic Blood Pressure	4 hours	Systolic blood pressure will be measured in millimeters of mercury every hour for 4 hours.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States