GentleFit Non-Invasive Ventilation (NIV) Interface Trial

Not yet recruiting

• Conditions: Device Ineffective; Device Induced Injury

• Registration Number: NCT06833294
• Lead Sponsor: Children's Hospital of Philadelphia

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 Timeline

• Study First Submitted: 2025-01-27
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Study Start: 2025-07-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pressure delivered by GentleFit Nasal Mask	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	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 Outcome Measures

Name	Time	Method
Clinical Parameters - Vital Sign - Transcutaneous Carbon Dioxide	24 hours	To monitor and record Transcutaneous Carbon Dioxide (TcPCO2) when applicable, over 24 hours.
Skin Integrity	24 hours	To monitor skin integrity in compliance with Respiratory Care Procedure "Non- Invasive Ventilation Interface Skin Assessment". Skin assessments will be conducted per hospital policy as standard of care and be monitored over 24 hours. When a pressure injury is present, clinicians will use a pressure injury staging system from the National Pressure Injury Advisory Panel (NPIAP) to grade severity of skin injury when indicated. Pressure injuries will be numerically staged ( Stage 1, 2, 3 or 4), if the type of tissue injured can be visualized or directly palpated. If the wound base cannot be evaluated, classify as: a) Deep Tissue Pressure Injury (DTPI) b) Unstageable. If on a mucosal membrane, document, but do not stage.; The numerical staging system does NOT imply linear progression of pressure injuries from Stage 1 through Stage 4, nor does it imply healing from Stage 4 through Stage 1.
Usability - Ease of Use	24 hours	To evaluate clinician opinion of ease of use of GentleFit NIV interfaces and headgear in pediatric subjects.; Clinicians will complete a 5 question REDCap survey on GentleFit NIV interfaces compared to standard of care interfaces the subject is using. The clinician will rate ease of use on a scale of 1-5 with 1 rating as difficult, up to 5 being easiest over 24 hours. Comment sections are provided for free text.
Usability - Overall Fit	24 hours	To evaluate clinician opinion of the overall fit GentleFit NIV interfaces and headgear in pediatric subjects.; Clinicians will complete a 5 question REDCap survey on GentleFit NIV interfaces compared to standard of care interfaces the subject is using. The clinician will evaluate the overall fit and appropriate of size of headgear and interfaces with yes/no questions over 24 hours. Comment sections are provided for free text.
Clinical Parameters - Vital Sign - Oxygen Saturation	24 hours	To monitor and record Oxygen Saturation (SpO2), per non-invasive ventilation standard of care, over 24 hours.
Clinical Parameters - Vital Sign - Respiratory Rate	24 hours	To monitor and record Respiratory Rate (RR), per non-invasive ventilation standard of care, over 24 hours.
Clinical Parameters - Vital Sign - Heart Rate	24 hours	To monitor and record Heart Rate (HR), per non-invasive ventilation standard of care, over 24 hours.
Clinical Parameters - Ventilator Values	24 hours	Accurate fit is assessed by ensuring that the ventilator pressures set are delivered with accuracy while preventing skin breakdown due to inaccurate fit. Ordered verses measured ventilator settings will be recorded over 24 hours.
Occurrence of Adverse Events	24 hours	Presence or increased frequency/severity of events that would necessitate discontinuation of an interface. The frequencies of Adverse Events (AE)s by type, body system, severity, and relationship to study interface will be summarized over 24 hours. AE incidence will be summarized along with the corresponding exact binomial 95% two-sided confidence intervals.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States