Evaluating vocal fold motion in children on noninvasive ventilation
Point-of-Care Ultrasound to Detect Vocal Fold Motion Impairment on Pediatric Patients on Noninvasive Positive Pressure Ventilation
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Queens, New York) |
| Trial ID | NCT06406725 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Queens, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.