Recruiting

Observational Study

Sponsor:

Nemours Children's Clinic

Code:

NCT06406725

Conditions

Vocal Cord Dysfunction

Vocal Cord Paralysis

Vocal Cord Paresis

Recurrent Laryngeal Nerve Palsy

Recurrent Laryngeal Nerve Injuries

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Point-of-Care Ultrasound of the Airway

Study Details

Brief 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?

Conditions

Vocal Cord Dysfunction

Vocal Cord Paralysis

Vocal Cord Paresis

Recurrent Laryngeal Nerve Palsy

Recurrent Laryngeal Nerve Injuries

Study ID

NCT06406725

Start date

Mar 30, 2024

Status verified date

Apr, 2026

Completion date

May 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 0 to 18 years
  • Scheduled to receive a fiberoptic nasolaryngoscopy with the otolaryngology team to assess for vocal fold motion impairment
  • Status post great vessel, esophageal, or tracheal surgery that could disrupt the recurrent laryngeal nerve

Exclusion Criteria:

  • Tracheostomy in place
  • Age >18 years
  • History of vocal cord paralysis/paresis
  • Patients who cannot have their neck placed in a neutral or slightly extended position due to injury or ligament laxity

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Interventions

Point-of-Care Ultrasound of the Airway

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.

Primary outcome measure

  • VFMI [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

April Slamowitz, MD

718-470-3000arslamowitz@gmail.com

Catherine Geller, MD

718-470-3000cgeller1@northwell.edu

Locations

Cohen Children's Medical Center

Recruiting

Queens, New York, United States, 11040

Contacts

April Slamowitz, MD

718-470-3000aslamowitz@northwell.edu

Catherine Geller, MD

718-470-3000cgeller@northwell.edu

More Information

Sponsor

Nemours Children's Clinic

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-05-06.