Clinical Trial

Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure

Recruiting
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Summary
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?
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-05-06.
Trial Details
NCT Number NCT06406725
Lead Sponsor Nemours Children's Clinic
Conditions Vocal Cord Dysfunction, Vocal Cord Paralysis, Vocal Cord Paresis, Recurrent Laryngeal Nerve Palsy, Recurrent Laryngeal Nerve Injuries
Enrollment 50 participants
Start Date 2024-03-30
Primary Completion 2028-03-30 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-06