Evaluating vocal fold motion in children on noninvasive ventilation
Official title: Point-of-Care Ultrasound to Detect Vocal Fold Motion Impairment on Pediatric Patients on Noninvasive Positive Pressure Ventilation
Run by Nemours Children's Clinic · NCT06406725 · Data updated 2026-11-12
This study is testing if using ultrasound can safely check how well the vocal folds are moving in kids on noninvasive ventilation in the ICU compared to a standard method that might be riskier.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 18 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Queens, New York) |
| Status | Recruiting |
| Started | March 30, 2024 |
| Main results expected | March 30, 2028 |
| Study ends | May 30, 2028 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT06406725 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 0 to 18 years who are scheduled for fiberoptic nasolaryngoscopy to assess vocal fold motion impairment after specific surgeries.
✕Probably not a fit
Patients with a history of vocal cord paralysis or those who cannot maintain a neutral neck position due to injury will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess vocal fold motion impairment (VFMI) in pediatric patients receiving noninvasive positive pressure ventilation (NIV PPV) in the intensive care unit. Participants will undergo two ultrasounds of their vocal folds: one while on NIV PPV and another after being weaned off. The results will be compared to the gold standard of fiberoptic nasolaryngoscopy (FNL) to determine the reliability of point-of-care ultrasound (POCUS) in detecting VFMI. The study seeks to address the potential risks associated with FNL in this vulnerable population.
Why it matters
Potential benefit: If successful, this study could provide a safer, noninvasive method for detecting vocal fold motion impairment in children, reducing the need for more invasive procedures.
How similar studies have gone: While the use of POCUS for VFMI detection is a novel approach, similar studies have shown promise in utilizing noninvasive techniques for assessing airway conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Cohen Children's Medical Center
Queens, New York, United States Recruiting
Study contacts
- Study coordinator: April Slamowitz, MD
- Email: arslamowitz@gmail.com
- Phone: 718-470-3000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.