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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254859
• Other study ID #: THYRO-SOUND2024
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Fujian Medical University
• Contact: Bo Wang Professor, MD
• Phone: +13959123550
• Email: wangbo[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Traditional thyroid surgery.
The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	Neural Width	Recorded width of the recurrent laryngeal nerve in millimeters.	During surgery.
Secondary	Is there branching	Note if the recurrent laryngeal nerve branches.	During surgery.
Secondary	Number of neural branches	If there are branches in the recurrent laryngeal nerve, record the number of branches.	During surgery.