Voice Rest and Injection Laryngoplasty

NCT ID: NCT05542550

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-12-31

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.

Conditions

Vocal Cord Paralysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Voice Rest

48 hours of voice rest prescribed following injection

Group Type: ACTIVE_COMPARATOR

Voice Rest

Intervention Type: BEHAVIORAL

Voice rest restricting patient phonation

No voice rest

No voice rest required following injection

Group Type: EXPERIMENTAL

No Voice Rest

Intervention Type: BEHAVIORAL

No Voice rest

Interventions

Voice Rest

Voice rest restricting patient phonation

Intervention Type: BEHAVIORAL

No Voice Rest

No Voice rest

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

James Daniero, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James J Daniero, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

James J Daniero, MD

Role: CONTACT

jjd5h@uvahealth.org

4349242040

Facility Contacts

James J Daniero, MD

Role: primary

jjd5h@uvahealth.org

434-924-2040

Elena Miller

Role: backup

em8zk@uvahealth.org

4342433607

Other Identifiers

HSR220245

Identifier Type: -

Identifier Source: org_study_id