Pilot of New GentleFit NIV Interfaces for Size and Fit With Pediatric Patients
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Pressure delivered by GentleFit Nasal Mask
Overview
Brief Summary
The primary objective is to compare pressure achieved by GentleFit Non-Invasive Ventilation (NIV) nasal mask and nasal prong to standard of care interface. Secondary objectives include to monitor skin integrity, clinical parameters, and adverse events. Additionally, to evaluate clinician opinion of ease of application and overall fit of GentleFit NIV interfaces and headgear.
Detailed Description
Current NIV interfaces commercially available do not address all size and anatomical gaps present in the pediatric population. To overcome this challenge, nasal mask and nasal prong prototype interfaces have been designed to fill some of the current size gap. These interfaces, known as GentleFit NIV, need to be trialed to ensure appropriateness of design and patient tolerance for 4-8 hour application intervals, as is standard of practice for current devices on the market.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 38 Weeks to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children with corrected gestational age ≥ 38 weeks through 3 years old weighing \> 3.5kg.
- •Children who are on clinically stable Non-Invasive Ventilation (NIV) settings, defined as no escalation in support in the last 6-8 hours.
- •Children whose nares, face, or head fit at least one of the GentleFit NIV interfaces.
- •Parental/guardian permission (informed consent).
Exclusion Criteria
- •Children whose nares, face, or head do not fit the manufacturer sizing guide for nasal mask and nasal prongs.
- •Facial anomalies (e.g. cleft lip).
- •Existing skin injury present in an area where GentleFit NIV interfaces or headgear would contact skin.
- •Patient's emergent condition.
Arms & Interventions
Children requiring Non-Invasive Ventilation (NIV)
Children with corrected gestational age ≥ 38 weeks through 3 years old weighing > 3.5kg requiring NIV.
Intervention: GentleFit Mask, GentleFit Prong, Standard of Care Interface (Device)
Outcomes
Primary Outcomes
Pressure delivered by GentleFit Nasal Mask
Time Frame: 24 hours
To compare pressure achieved by GentleFit Non-invasive Ventilation (NIV) nasal mask compared to standard of care interface. Set Peak End Expiratory Pressure (PEEP) and Peak Inspiratory Pressure (PIP) settings and delivered PEEP, PIP and Mean Airway Pressure (MAP) will be monitored over 24 hours. Data collected from the ventilator on each interface, will be compared to the same values with standard of care interface.
Pressure delivered by GentleFit Nasal Prongs
Time Frame: 24 hours
To compare pressure achieved by GentleFit NIV nasal prong compared to standard of care interface. Set PEEP and PIP settings and delivered PEEP, PIP and Mean Airway Pressure (MAP) will be monitored over 24 hours. Data collected from the ventilator on each interface, will be compared to the same values with standard of care interface.
Secondary Outcomes
- Skin Integrity(24 hours)
- Usability - Ease of Use(24 hours)
- Usability - Overall Fit(24 hours)
- Clinical Parameters - Vital Sign - Oxygen Saturation(24 hours)
- Clinical Parameters - Vital Sign - Respiratory Rate(24 hours)
- Clinical Parameters - Vital Sign - Heart Rate(24 hours)
- Clinical Parameters - Vital Sign - Transcutaneous Carbon Dioxide(24 hours)
- Clinical Parameters - Ventilator Values(24 hours)
- Occurrence of Adverse Events(24 hours)