Voice Rest and Injection Laryngoplasty

Vocal Cord Paralysis Clinical Trial

Official title:

Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542550
• Other study ID #: HSR220245
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Virginia
• Contact: James J Daniero, MD
• Phone: 4349242040
• Email: jjd5h[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Vocal Cord Paralysis

Intervention

Behavioral:
• Voice Rest
Voice rest restricting patient phonation
• No Voice Rest
No Voice rest

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-perceived voice improvement	Voice Handicap Index - 10. Scale range 0-40. Lower score designates lower voice impairment	2 weeks
Secondary	GRBAS- Grade, Roughness, Breathiness, Asthenia, Strain	Clinician-perceived improvement in voice. Range is 0-15. Lower score indicates lower perceived vocal impairment	2 weeks
Secondary	Phonation threshold pressure	Objective aerodynamic measure	2 weeks