Pediatric Helmet CPAP Pilot Study

NCT04764929 | Terminated Results FDA Device

• 1 other identifier: AAAT5640
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis, Viral; Pneumonia, Viral; Pneumonia, Bacterial

Outcome Measures

Primary Outcomes (1)

• 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.

  Four hours

Secondary Outcomes (4)

• Respiratory Rate

  4 hours

• Heart Rate

  4 hours

• Oxygen Saturation

  4 hours

• Systolic Blood Pressure

  4 hours

Study Arms (1)

Helmet CPAP

EXPERIMENTAL

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

Interventions

Helmet CPAP DEVICE

Vyatil nonpowered oxygen tent system

Helmet CPAP

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Bronchiolitis, Viral; Pneumonia, Viral; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Virus Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pneumonia; Bacterial Infections; Bacterial Infections and Mycoses

Results Point of Contact

• Title: Patrick Wilson, MD
• Organization: Columbia University

ptw2107@cumc.columbia.edu

212-305-8458

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: August 7, 2021
• Primary Completion: May 19, 2022
• Study Completion: June 14, 2023
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)