Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05542550
Study type Interventional
Source University of Virginia
Contact James J Daniero, MD
Phone 4349242040
Email jjd5h@uvahealth.org
Status Recruiting
Phase N/A
Start date August 1, 2023
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT02244697 - The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children N/A
Recruiting NCT06227039 - Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures N/A
Recruiting NCT04396912 - Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort
Completed NCT04458818 - A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study. N/A
Recruiting NCT06406725 - Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure
Completed NCT00213616 - Bilateral Laryngeal Paralysis Reinnervation N/A
Completed NCT00382369 - Whole Genome Scan of Extended Families With Familial Vocal Cord Paralysis N/A
Completed NCT01824849 - Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis N/A
Completed NCT04315415 - A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid N/A
Completed NCT04839276 - Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis Phase 4
Completed NCT00845442 - Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator N/A
Recruiting NCT00213863 - Implantation of Porous Titanium Prosthesis in Laryngeal Surgery Phase 2
Completed NCT04764604 - Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment N/A
Recruiting NCT03634956 - Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery N/A
Not yet recruiting NCT06078527 - Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort N/A