Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery

May 17, 2025 updated by: Bo Wang,MD, Fujian Medical University
This study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. By analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals and their correlation with voice quality outcomes. The goal is to enhance clinical understanding and surgical practices, allowing for more precise assessments of nerve function, informed surgical interventions, and improved postoperative patient well-being.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research project conducts a detailed exploration into the fluctuations of intraoperative recurrent laryngeal nerve monitoring signals during thyroid surgery and their subsequent effects on the voice quality of patients after surgery. The study meticulously analyzes a comprehensive dataset comprised of surgical records and voice analyses conducted before and after the procedure. The primary objective is to pinpoint specific trends and changes in the nerve monitoring signals and to determine how these alterations correlate with the postoperative acoustic characteristics of patients' voices. By establishing a clear link between intraoperative signal dynamics and postoperative voice outcomes, the investigation aims to advance the field of thyroid surgery. This includes providing surgeons with critical insights for the precise evaluation of recurrent laryngeal nerve functionality, enabling targeted interventions during operations, and ultimately contributing to the enhancement of patients' quality of life following surgery. Through this rigorous analysis, the study seeks to contribute valuable knowledge to the surgical community, facilitating improved patient care and outcomes in thyroid surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Principal Investigator:
          • Bo Wang, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

People with thyroid cancer who are planned to undergo traditional surgical treatment.

Description

Inclusion Criteria:

  • Age 20-60 years old.
  • Planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection.

Exclusion Criteria:

  • History of past head and neck surgeries.
  • Pronunciation system defect and disorder history.
  • History of vocal cord polyps or nodules.
  • History of upper respiratory tract infection in the 2 weeks before surgery or postoperative infection history.
  • History of neurological disorders.
  • Abnormalities in the throat.
  • Preoperative damage to throat morphology or motor function.
  • Preoperative functional voice or language disorders, noticeable hoarseness, or difficulty in pronunciation.
  • Pre- and postoperative laryngoscopic examination showing vocal cord paralysis and arytenoid joint dislocation.
  • Neurological disorders causing abnormal throat function.
  • Patient unable to cooperate with VHI (Voice Handicap Index) assessment and voice spectrum examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Normal Signal Group.
During the surgical procedure, there was no occurrence of a decrease in recurrent laryngeal nerve signals or a decrease of less than 10%.
Procedure: Traditional thyroid surgery.
The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.
Signal Decrease 10-50%.
During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 10-50%.
Procedure: Traditional thyroid surgery.
The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.
Signal Decrease 50-90%.
During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 50-90%.
Procedure: Traditional thyroid surgery.
The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.
Signal Absence Group.
During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by more than 90% or completely disappeared.
Procedure: Traditional thyroid surgery.
The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraoperative electromyographic signals.
Time Frame: During the surgery, record R1 and V1 signals when initially identifying the recurrent laryngeal nerve or vagus nerve. After the surgery, record R2 and V2 signals upon re-identification of the recurrent laryngeal nerve or vagus nerve.
Recording intraoperative electromyographic signals, including vagus nerve V1 and V2 signals, recurrent laryngeal nerve R1 and R2 signals.
During the surgery, record R1 and V1 signals when initially identifying the recurrent laryngeal nerve or vagus nerve. After the surgery, record R2 and V2 signals upon re-identification of the recurrent laryngeal nerve or vagus nerve.
Voice analysis data(SPL)
Time Frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Recording data(SPL) of voice tests before and after the surgery, sound pressure level in dB(A)
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Voice analysis data(F0)
Time Frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Recording data(F0) of voice tests before and after the surgery, F0 in Hz
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Voice analysis data(Jitter)
Time Frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Recording data(Jitter) of voice tests before and after the surgery, Jitter in percentage
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Voice analysis data(Shimmer)
Time Frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Recording data(Shimmer) of voice tests before and after the surgery, Shimmer in percentage
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
RBH
Time Frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Conducted by an otolaryngologist, the RBH assessment includes R (Roughness), B (Breathiness), and H (Hoarseness).
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
VHI-30
Time Frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Voice Handicap Index, including a scale with 30 items.The full, non-abbreviated title of the VHI-30 scale is the "Voice Handicap Index-30," and it is translated as the "Voice Disorder Severity Index." The scale ranges from a minimum score of 0 to a maximum of 120, with higher scores indicating poorer outcomes.
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Neural Width
Time Frame: During surgery.
Recorded width of the recurrent laryngeal nerve in millimeters.
During surgery.
Is there branching
Time Frame: During surgery.
Note if the recurrent laryngeal nerve branches.
During surgery.
Number of neural branches
Time Frame: During surgery.
If there are branches in the recurrent laryngeal nerve, record the number of branches.
During surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THYRO-SOUND2024

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

product manufactured in and exported from the U.S.

No

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