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Clinical Trials/NCT06254859
NCT06254859
Recruiting
N/A

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

Fujian Medical University1 site in 1 country100 target enrollmentMarch 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Thyroid Cancer
Sponsor
Fujian Medical University
Enrollment
100
Locations
1
Primary Endpoint
Intraoperative electromyographic signals.
Status
Recruiting
Last Updated
11 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
December 31, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fujian Medical University
Responsible Party
Principal Investigator
Principal Investigator

Bo Wang,MD

Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor

Fujian Medical University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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)

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

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

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

Secondary Outcomes

  • 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.)
  • Number of neural branches(During surgery.)
  • Is there branching(During surgery.)

Study Sites (1)

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