Clinical trial NCT05542550: Voice Rest and Injection Laryngoplasty
Official title: Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vocal Cord Paralysis
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2022-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to one of two arms: no voice rest following injection and 48 hours voice rest following injection
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years old
2. Undergoing injection augmentation by Dr. McGarey, Dr. Torrecillas, or Dr. Daniero for the following conditions:

   1. Glottic insufficiency from atrophy, scar, or presbylarynx
   2. Unilateral or bilateral vocal fold immobility
   3. Unilateral or bilateral vocal fold hypomobility

Exclusion Criteria:

1. Prior history of head and neck radiation.
2. Active or recent (within 3 months) chemotherapy.
3. Age \<18 years old
4. Incarcerated individuals will be excluded due to inability to enroll in post-intervention clinic visit
5. Presence of posterior glottic stenosis
6. Presence of acute laryngeal injury
7. Bedside inpatient injection augmentation
8. Vocal fold Injection with steroids or cidofovir

Primary outcomes:
measure: Patient-perceived voice improvement
timeFrame: 2 weeks
Secondary outcomes:
measure: GRBAS- Grade, Roughness, Breathiness, Asthenia, Strain
timeFrame: 2 weeks
measure: Phonation threshold pressure
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: James J Daniero, MD
role: PRINCIPAL_INVESTIGATOR
References: