Actively Recruiting

Age: 1Day - 18Years
All Genders
Healthy Volunteers
ID06406725

Point-of-Care Ultrasound to Detect Vocal Fold Motion Impairment in Pediatric Patients Using Noninvasive Positive Pressure Ventilation

Led by Nemours Children's Clinic ยท Updated on 2026-05-06

50

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate vocal fold motion impairment (VFMI) in children admitted to the pediatric intensive care unit who are using noninvasive positive pressure ventilation (NIV PPV). VFMI can result from surgeries affecting the airway, esophagus, or great vessels and may cause voice problems, feeding difficulties, aspiration risk, and airway issues leading to serious health problems. The study investigates whether point-of-care ultrasound (POCUS) can reliably detect VFMI compared to the standard fiberoptic nasolaryngoscopy (FNL), which can be risky in pediatric patients. Participants will undergo two ultrasound scans of their vocal folds: one while on NIV PPV and another after being weaned off it. Between these scans, the usual FNL procedure will be performed by the otolaryngology team to assess the vocal fold motion. This observational study focuses on comparing ultrasound results with FNL findings to determine if POCUS is a safe and effective screening tool for VFMI in this setting. During the study, children will have their vocal folds examined using ultrasound and FNL as part of their care. Researchers will compare these results to measure VFMI presence over a two-year period. The study will monitor the safety and accuracy of ultrasound as a non-invasive method, aiming to reduce the risks associated with FNL. Participants will be followed up to assess outcomes related to vocal fold motion impairment, with the entire process integrated into their clinical treatment timeline.

CONDITIONS

Brief Title

Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure

Who Can Participate

Age: 1Day - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Tracheostomy in place
  • Age over 18 years
  • History of vocal cord paralysis or paresis
  • Cannot have neck placed in a neutral or slightly extended position due to injury or ligament laxity

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Diagnostic Evaluation

Duration - Within 1 day

Participants undergo point-of-care ultrasound of the airway while on noninvasive positive pressure ventilation and after removal, alongside standard fiberoptic nasolaryngoscopy (FNL) to assess vocal fold motion impairment.

1 to 2 visits depending on timing of ultrasound and FNL

Long-term Monitoring

Duration - Up to 2 years

Participants are observed for outcomes related to vocal fold motion impairment over a period of up to 2 years.

Follow-up visits as per clinical care

Trial Site Locations

Total: 1 location

1

Cohen Children's Medical Center

Queens, New York, United States, 11040

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Research Team

A

April Slamowitz, MD

C

Catherine Geller, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Dysphagia Outcomes Following Surgical Management of Unilateral Vocal Fold Immobility in Children: A Systematic Review.

Kastley Marvin, Michael Coulter, Christopher Johnson...

https://pubmed.ncbi.nlm.nih.gov/35290106