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_TEST
    Patients 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 PPV
    We 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

Locations (1)

FacilityCityStateZIPSite coordinators
Cohen Children's Medical CenterQueensNew York11040
April Slamowitz, MD
718-470-3000
Catherine Geller, MD
718-470-3000

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