Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intraoperative electromyographic signals.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-60 years old.
- •Planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection.
排除标准
- •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.
结局指标
主要结局
Intraoperative electromyographic signals.
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- 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.)
研究者
Bo Wang,MD
Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor
Fujian Medical University