Pediatric Helmet CPAP Pilot Study

Sponsor
Patrick Wilson (Other)
Overall Status
Recruiting
CT.gov ID
NCT04764929
Collaborator
(none)
30
1
1
12.8
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Helmet CPAP
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Helmet CPAP for Infants and Pediatric Patients With Acute Respiratory Distress
Actual Study Start Date :
Aug 7, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Helmet CPAP

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
Vyatil nonpowered oxygen tent system

Outcome Measures

Primary Outcome Measures

  1. Tolerability of helmet CPAP [Four hours]

    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.

Secondary Outcome Measures

  1. Respiratory rate [Four hours]

    We will measure respiratory rate in breaths per minute every hour blood pressure every hour for four hours.

  2. Heart rate [Four hours]

    We will measure heart rate in beats per minute every hour

  3. Oxygen saturation [Four hours]

    We will measure pulse oxygen saturation as a percent every hour

  4. Systolic blood pressure [Four hours]

    We will measure systolic blood pressure in millimeters of mercury every hour

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Medical Center New York New York United States 10032

Sponsors and Collaborators

  • Patrick Wilson

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patrick Wilson, Associate Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier:
NCT04764929
Other Study ID Numbers:
  • AAAT5640
First Posted:
Feb 21, 2021
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022