Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure

Vocal Cord Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406725
• Other study ID #: 23-0649_A
• Status: Recruiting
• Start date: March 30, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: Northwell Health
• Contact: April Slamowitz, MD
• Phone: 718-470-3000
• Email: arslamowitz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Description:

Vocal fold motion impairment (VFMI) is a known sequela of airway, esophageal, and great vessel surgery, due to direct damage of the recurrent laryngeal nerve(s). VFMI can be diagnosed with the gold standard approach, direct visualization using fiberoptic nasolaryngoscopy (FNL).

Paralysis of the vocal folds leads to glottic incompetence, which can cause dysphonia, feeding and swallowing difficulties, risk of aspiration, and airway compromise. Taken together, these symptoms can then lead to poor weight gain, chronic aspiration, need for hospitalization, recurrent pneumonias, and needs for alternative routes of nutrition.

The presence of VFMI after cardiovascular surgeries occurs anywhere from 8.8% to 58.7%, depending on the procedure performed and institution. Nerve injury may recover spontaneously, however the extent and timing are variable.

Although FNL has been historically thought to be a safe procedure, recent literature and case reports have noted that FNL is potentially noxious to the pediatric patient. This noxious stimuli can lead to tachycardia, tachypnea, oxygen desaturation, epistaxis, vasovagal events, laryngospasm, and aspiration events. In pediatric patients who have undergone cardiovascular surgery, the noxious stimuli from FNL can be potentially life-threatening. Specifically for those with single ventricle physiology and pulmonary hypertension, the noxious FNL can lead to a rapid increase in pulmonary vascular resistance, which can cause the pulmonary arterial pressure to exceed that of the systemic vascular pressure. This could then lead to an acute decrease in the right ventricular ejection fraction, right heart failure, and even sudden death.

Recently, laryngeal ultrasound (LUS) has been proposed as a safer, non-invasive modality to help screen patients who are at risk of VFMI. It has high sensitivity and specificity for VFMI and is simple to before by radiology technicians or bedside providers in the pediatric intensive care unit with POCUS.

This study aims to answer the question: Can POCUS be used to reliably detect VFMI while pediatric patients on supported with NIV PPV? We predict that LUS will have high sensitivity and specificity to detect VFMI, despite the addition of NIV PPV.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Paresis
• Recurrence
• Recurrent Laryngeal Nerve Injuries
• Recurrent Laryngeal Nerve Palsy
• Vocal Cord Dysfunction
• Vocal Cord Paralysis
• Vocal Cord Paresis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Cohen Children's Medical Center	Queens	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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