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NCT06833294 · ClinicalTrials.gov registry record
GentleFit Non-Invasive Ventilation (NIV) Interface Trial
A clinical trial, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- 4
- Enrollment target
NCT06833294: Clinical Trial study, sponsored by Children's Hospital of Philadelphia.
NCT06833294 is a clinical trial that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06833294 was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE GentleFit Mask, GentleFit Prong, Standard of Care Interface
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2025-10-24 |
| Est. Completion | 2026-01-20 |
Why NCT06833294 stopped before completion
NCT06833294 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which GentleFit Mask, GentleFit Prong, Standard of Care Interface is the first listed.
NCT06833294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06833294 about?
NCT06833294 is a clinical study titled "GentleFit Non-Invasive Ventilation (NIV) Interface Trial". 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 ...
What is the current status of trial NCT06833294?
This trial is currently terminated. The enrollment target is 4 participants. The study started on 2025-10-24. Estimated completion is 2026-01-20.
What interventions are being tested in trial NCT06833294?
The interventions under investigation include: GentleFit Mask, GentleFit Prong, Standard of Care Interface (DEVICE).
Who is sponsoring clinical trial NCT06833294?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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