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NCT Number: NCT06254859

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

Bo Wang Porfessor, MD

CONTACT

[email protected]

+13959123550

Bo Wang, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional thyroid surgery.

Procedure

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

Primary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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).

  2. 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.

  3. Neural Width

    Time frame: During surgery.

    Recorded width of the recurrent laryngeal nerve in millimeters.

  4. Is there branching

    Time frame: During surgery.

    Note if the recurrent laryngeal nerve branches.

  5. Number of neural branches

    Time frame: During surgery.

    If there are branches in the recurrent laryngeal nerve, record the number of branches.

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Wang Professor, MD

CONTACT

[email protected]

+13959123550

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2024
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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