GentleFit Non-Invasive Ventilation (NIV) Interface Trial

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Device Induced Injury; Device Ineffective

Treatments: Device: GentleFit Mask, GentleFit Prong, Standard of Care Interface

Study type: Observational

Funder types: Other

Identifiers

NCT06833294

23-021144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 38 weeks to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children with corrected gestational age ≥ 38 weeks through 3 years old weighing > 3.5kg.
2. Children who are on clinically stable Non-Invasive Ventilation (NIV) settings, defined as no escalation in support in the last 6-8 hours.
3. Children whose nares, face, or head fit at least one of the GentleFit NIV interfaces.
4. Parental/guardian permission (informed consent).

Exclusion criteria

1. Children whose nares, face, or head do not fit the manufacturer sizing guide for nasal mask and nasal prongs.

2. Facial anomalies (e.g. cleft lip).

3. Existing skin injury present in an area where GentleFit NIV interfaces or headgear would contact skin.

4. Patient's emergent condition.

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Trial design

48 participants in 1 patient group

Children requiring Non-Invasive Ventilation (NIV)

Description:

Children with corrected gestational age ≥ 38 weeks through 3 years old weighing \> 3.5kg requiring NIV.

Treatment:

Device: GentleFit Mask, GentleFit Prong, Standard of Care Interface