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

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: Recruiting
• Conditions: Thyroid Cancer, Papillary; Thyroid Cancer
• Intervention / Treatment: Procedure: Traditional thyroid surgery.

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: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Bo Wang Professor, MD; Phone Number: +13959123550; Email: wangbo@fjmu.edu.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Principal Investigator: Bo Wang, MD
      • Contact: Bo Wang Porfessor, MD; Phone Number: +13959123550; Email: wangbo@fjmu.edu.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Intraoperative electromyographic signals.	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)	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)	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)	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)	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

Outcome Measure	Measure Description	Time Frame
RBH	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	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	Recorded width of the recurrent laryngeal nerve in millimeters.	During surgery.
Is there branching	Note if the recurrent laryngeal nerve branches.	During surgery.
Number of neural branches	If there are branches in the recurrent laryngeal nerve, record the number of branches.	During surgery.

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: thyroid cancer; acoustic analysis
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Adenocarcinoma, Papillary; Thyroid Cancer, Papillary; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID 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