Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial

Conditions
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Vocal Cord Paralysis

Intervention / Treatment
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* Behavioral: Voice Rest
* Behavioral: No Voice Rest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age >18 years old 4. Undergoing injection augmentation by Dr. McGarey or Dr. Daniero for the following conditions: Glottic insufficiency from atrophy, scar, or presbylarynx Unilateral or bilateral vocal fold immobility Unilateral or bilateral vocal fold hypomobility Additional considerations Patient can be included if they have undergone a previous injection Any injection material will be included Injections in both the operating room and office will be included Non-english speakers will be included, as long as they are able to complete the VHI-10 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Randomized to one of two arms: no voice rest following injection and 48 hours voice rest following injection
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Voice Rest<br>48 hours of voice rest prescribed following injection | Behavioral: Voice Rest<br>* Voice rest restricting patient phonation<br>|
| Experimental: No voice rest<br>No voice rest required following injection | Behavioral: No Voice Rest<br>* No Voice rest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-perceived voice improvement | VHI-10 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRBAS | Physician-perceived improvement in voice | 2 weeks | 
| Phonation threshold pressure | OBjective aerodynamic measure | 2 weeks |