Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure
Part of paid clinical trials in Queens, New York.
- Sponsor
- Nemours Children's Clinic
- Study ID
- NCT06406725
- Status
- Recruiting
Conditions
- Recurrent Laryngeal Nerve Injuries
- Recurrent Laryngeal Nerve Palsy
- Vocal Cord Dysfunction
- Vocal Cord Paralysis
- Vocal Cord Paresis
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Day - 18 Years
- Healthy Volunteers
- Accepted
Interventions
- Point-of-Care Ultrasound of the Airway — DIAGNOSTIC_TESTPatients who are recruited will have an ultrasound performed of their larynx while they are on noninvasive positive pressure ventilation and then a second ultrasound when they are removed from noninvasive positive pressure ventilation. Between the two ultrasounds, the otolaryngology team will perform their fiberoptic nasolaryngoscopy, as per standard unit protocol and patient care.
Study Details
The goal of this prospective, observational study is to evaluate for the presence of vocal fold motion impairment (VFMI) in the children admitted to the pediatric intensive care unit on noninvasive positive pressure ventilation (NIV PPV). Participants will have two ultrasounds of their vocal folds performed, once while on NIV PPV and once after weaned off of the NIV PPV. This results of these scans will be reviewed against one another and against the gold standard, fiberoptic nasolaryngoscopy (FNL). The main question this study aims to answer is: Can POCUS be used to reliably detect VFMI while pediatric patients on supported with NIV PPV?
Key Dates
- Start date
- Mar 30, 2024
- Status verified
- Apr 2026
- Primary completion
- Mar 30, 2028
- Completion
- May 30, 2028
Study Design
- Enrollment
- 50 participants (estimated)
Arms
- Arm: NIV PPVWe will recruit patients who are currently on noninvasive positive pressure ventilation (NIV PPV) who are scheduled for fiberoptic nasolaryngoscopy (FNL) with the otolaryngology team for evaluation of vocal fold motion impairment (VFMI).
Primary Outcome Measure
VFMI [ Time Frame: 2 years ]
Central Contacts
- April Slamowitz, MD718-470-3000
- Catherine Geller, MD718-470-3000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cohen Children's Medical Center | Queens | New York | 11040 |
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