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

NCT06254859 | Recruiting

• 1 other identifier: THYRO-SOUND2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Cancer; Thyroid Cancer, Papillary

Keywords

acoustic analysis; thyroid cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• RBH

  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

  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

  During surgery.

• Is there branching

  During surgery.

• Number of neural branches

  During surgery.

Study Arms (4)

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.

Signal Decrease 10-50%.

During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 10-50%.

Procedure: Traditional thyroid surgery.

Signal Decrease 50-90%.

During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 50-90%.

Procedure: Traditional thyroid surgery.

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.

Interventions

Traditional thyroid surgery. PROCEDURE

The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.

Normal Signal Group.; Signal Absence Group.; Signal Decrease 10-50%.; Signal Decrease 50-90%.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Bo Wang Professor, MD

CONTACT

+13959123550; wangbo@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 12, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)