An observational study in Thyroid Cancer and Thyroid Nodule, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by University of Virginia · Observational
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.
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.
819 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's planned enrollment of 45 is below the median of 160 across 267 observational studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →University of Virginia is the lead sponsor of 673 studies on the registry; 139 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients that are clinically referred for a thyroidectomy for known or potential cancer.
Other: No intervention: observational only
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
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.
Time frame: Baseline, 1 week following surgery, 3 months following surgery
Video flexible nasolaryngoscopy
This procedure is endoscopic and allows for visualization and audio/video recording of the vocal folds at rest and during speech
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 week following surgery, 3 months following surgery
Plan to share: No
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Started Apr 2019 (actual). Primary completion is estimated for Dec 2023, 55 months after the start.
Of 102 non-industry observational studies under Thyroid Neoplasms, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 311. This study's planned 55 months is below that.
Counting every sponsor, half of 113 studies reached it within 63 months; a quarter within 26 and three quarters within 311.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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