Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure

NCT06406725 | Recruiting DMC

• 1 other identifier: 23-0649_A
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• VFMI

  Our primary outcome measure will be the detection of vocal fold motion impairment on patients as detected by laryngeal point-of-care ultrasound while on NIV PPV.

  2 years

Study Arms (1)

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).

Diagnostic Test: Point-of-Care Ultrasound of the Airway

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.

NIV PPV

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients being seen in our institution's pediatric intensive care unit are the source of potential subjects. This is a 37-bed regional referral center with approximately 2500 admissions annually.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Cohen Children's Medical Center

Queens, New York, 11040, United States

RECRUITING

Related Publications (3)

• Ongkasuwan J, Ocampo E, Tran B. Laryngeal ultrasound and vocal fold movement in the pediatric cardiovascular intensive care unit. Laryngoscope. 2017 Jan;127(1):167-172. doi: 10.1002/lary.26051. Epub 2016 Apr 23.

  PMID: 27107409 BACKGROUND

• Marvin K, Coulter M, Johnson C, Friesen T, Morris K, Brigger MT. Dysphagia Outcomes Following Surgical Management of Unilateral Vocal Fold Immobility in Children: A Systematic Review. Otolaryngol Head Neck Surg. 2023 Apr;168(4):602-610. doi: 10.1177/01945998221084891. Epub 2023 Feb 5.

  PMID: 35290106 BACKGROUND

• Izadi S, Zendejas B, Meisner J, Kamran A, Mohammed S, Demehri F, Staffa S, Zurakowski D, Hseu A, Cunningham M, Choi S, Barnewolt C. Diagnostic Accuracy of Laryngeal Ultrasound for Evaluating Vocal Fold Movement Impairment in Children. J Pediatr Surg. 2024 Jan;59(1):109-116. doi: 10.1016/j.jpedsurg.2023.09.017. Epub 2023 Sep 22.

  PMID: 37845124 BACKGROUND

MeSH Terms

Conditions

Vocal Cord Dysfunction; Vocal Cord Paralysis; Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Laryngeal Nerve Injuries; Vagus Nerve Injuries; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

April Slamowitz, MD

CONTACT

718-470-3000; arslamowitz@gmail.com

Catherine Geller, MD

CONTACT

718-470-3000; cgeller1@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Intensivist

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: March 30, 2024
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)