Voice Outcomes Following Thyroidectomy

Voice Outcomes Following Thyroidectomy Compared to Surgeries That Do Not Involve Risk to the Laryngeal Nerves

This is an observational study of voice outcomes in participants following thyroidectomy or another head and neck surgery that does not involve risk to the larynx other than risks incurred due to intubation alone. These comparative (non-thyroidectomy) surgeries would not be expected to interfere with the primary nerves involved with voice production, so they would help to better understand the effect of intubation alone on voice outcomes.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer; Thyroid Nodule
• Intervention / Treatment: Other: No intervention: observational only

Detailed Description

Voice difficulty is a common complaint following thyroidectomy, and while the procedure risks injury to laryngeal nerves involved in voice production, voice difficulty is common even in the absence of evident injury to these nerves. The cause of voice change in these situations is not well defined, and multiple mechanisms have been suggested. Some potential mechanisms include trauma to the laryngeal skeleton from intraoperative manipulation of the strap muscles, cricothyroid muscle, thyroid, cartilage, or trachea. However, it is also possible that irritation due to intubation and edema to the neck and oral or pharyngeal soft tissues that develops after the surgery as a result of intubation plays a role in postoperative voice change. These mechanisms can occur in any operation requiring general endotracheal anesthesia even when the laryngeal nerves are not specifically at risk of injury.

The purpose of this study is to evaluate voice outcomes after thyroidectomy (both objective and subjective patient and clinician reported) and compare those to voice outcomes after other surgeries that do not put the recurrent or superior laryngeal nerves at risk or traumatize the laryngeal skeleton, but do require general endotracheal anesthesia. The primary assessment tool will be the Voice Handicap Index-10 (VHI-10), which is a questionnaire that asks about the patient's interpretation of his/her voice quality and the impact it is having on daily activities. Data analysis will be done to see if participants have a significant change in their pre-operation VHI-10 score at approximately 1 week and 3 months post-operation. Additional assessments tools will include nasolaryngoscopy and nasolaryngeal stroboscopy to assess global vocal fold function, Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) and computerized speech lab (CSL) acoustics to assess voice quality, and vocal aerodynamic analysis to determine air flow through the larynx.

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Bette F Ghamandi; Phone Number: 434-243-1558; Email: bjf8j@hscmail.mcc.virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Bette F Ghamandi, MHA, CCRP; Phone Number: 434-243-1558; Email: bjf8j@hscmail.mcc.virginia.edu
      • Sub-Investigator: James Daneiro, MD
      • Sub-Investigator: Bethany Horton, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults that have been clinically referred for thyroidectomy or another surgery requiring intubation but without risk to the laryngeal nerves or dissection adjacent to the larynx.

Description

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
4. Subject must be clinically referred for a thyroidectomy for known or potential cancer, or subject must be clinically referred for a surgery requiring intubation, but without risk to the laryngeal nerves or dissection adjacent to the larynx for the control group
5. As the VHI-10 is not available and validated in all languages, participants must be able to comprehend a validated version of the VHI-10 in their language

Exclusion Criteria:

1. Plan to include neck dissection in upcoming surgery (control group/non-thyroidectomy patients only)
2. Known to be pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Thyroidectomy; Patients that are clinically referred for a thyroidectomy for known or potential cancer.	Other: No intervention: observational only; No intervention: observational only
Other surgeries; Patients must be clinically referred for a surgery requiring intubation, but without risk to the laryngeal nerves or dissection adjacent to the larynx	Other: No intervention: observational only; No intervention: observational only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Voice Handicap Index-10 (VHI-10) score before and after surgery	This is a VHI-10 is a questionnaire that asks about the patient's interpretation of his/her voice quality and the impact it is having on daily activities.	Baseline, 1 week following surgery, 3 months following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Video flexible nasolaryngoscopy	This procedure is endoscopic and allows for visualization and audio/video recording of the vocal folds at rest and during speech	Within 24 hours following surgery
Video nasolaryngeal stroboscopy	This imaging is another form of nasolaryngoscopy but has the addition of a strobe light. The strobe light provides an optical illusion in which the vocal cords appear to be moving in slow motion on the video, even though its movement is unaltered.	Baseline, 1 week following surgery, 3 months following surgery
Vocal Aerodynamics Analysis	This assessment is performed by fitting the participant with a mask that is attached to a tube that goes just inside the participant's lips. This positioning allows for the participant to close his/her lips around the tube without occluding it. The participant is asked to produce repeated syllables like pi-pi-pi-pi-pi, which allows for airflow and air pressure to be measured and reflects vocal fold function.	Baseline, 1 week following surgery, 3 months following surgery
CAPE-V	The CAPE-V is a tool used for clinical auditory-perceptual assessment of voice. It is intended to describe the severity of various auditory attributes of a voice problem, and it is determined by the clinician's auditory assessment of the patient's voice.	Baseline, 1 week following surgery, 3 months following surgery
CSL acoustics	This assessment involves having the participant speak into a microphone. The patient says a few scripted sentences, as well as repeated sounds, which is then analyzed by the computer software. The assessment allows for determination of vocal loudness, pitch, and voice quality. Voice quality is determined based on measures including vocal shimmer, vocal jitter, and background noise in the voice. Shimmer measures variation in voice amplitude and jitter measures variation in frequency.	Baseline, 1 week following surgery, 3 months following surgery

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: David C Shonka, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Anticipated): December 15, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Thyroidectomy; Laryngeal Nerves; Voice problems
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: 20892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No