NCT05542550

Voice Rest and Injection Laryngoplasty

Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the subjective, objective, and aerodynamic impact of voice rest following injection augmentation and compare the outcomes to patients with no post-procedure voice restrictions.

Detailed description

Glottic insufficiency resulting from vocal fold immobility can have a significant negative impact on health and quality of life and is a major cause of dysphonia, dysphagia, and dyspnea. Vocal fold immobility can be unilateral or bilateral and complete or partial. Most commonly, it is caused by iatrogenic injury to the recurrent laryngeal nerve from thyroidectomy or anterior cervical disc fusion surgeries. Other causes include traumatic, idiopathic, malignant, and neurogenic. Variability exists in approach to surgical management. Degree of spontaneous recovery and thus timing of intervention varies based on severity and permanency of neurological injury. Initially described by Wilhelm Brünings in 1911, injection laryngoplasty, also known as injection augmentation, is a technique to improve glottic closure by injection of material to move the immobile vocal fold closer to midline. This improves voice quality and strain in patients with either unilateral or bilateral vocal fold hypomobility, immobility, atrophy, presbylarynx, vocal fold scar, and soft tissue loss. Improvement in glottic closure also results in better swallowing outcomes. Injection augmentation can be performed under general anesthesia in patients unable to tolerate the procedure while awake. Injection can be performed peroral, through a working channeled flexible laryngoscope, or a percutaneous approach. Percutaneous approaches can be further divided into transthyroid cartilage, transcricothyroid membrane, or transthyrohyoid membrane. All cases are performed under endoscopic guidance to ensure correct needle placement and adequate medialization of affected vocal fold. Congruent with the heterogeneity of injection laryngoplasty materials, approaches, and techniques, there also appears to be no data or expert consensus regarding voice rest following this procedure. This study aims to quantify the benefit of voice rest following vocal fold injection augmentation.

Conditions

• Vocal Cord Paralysis

Interventions

Type	Name	Description
BEHAVIORAL	Voice Rest	Voice rest restricting patient phonation
BEHAVIORAL	No Voice Rest	No Voice rest

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-09-15
• Last updated: 2024-01-19

Locations

1 site across 1 country: United States