Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 427
- 试验地点
- 1
- 主要终点
- the primary outcome was to measure the incidence of hoarseness
研究概览
简要总结
Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a criterion, and acoustic parameters, while also validating the efficacy of our research methods.
详细描述
The primary outcome of this study is the incidence of hoarseness on the day of surgery.
The secondary outcomes include the incidence of hoarseness at one month after surgery, as well as examining the correlation between acoustic parameters, risk factors, and the occurrence of hoarseness.
Investigator conducted a comparative analysis of risk factor for hoarseness in patients with different VHI-10 scores on the day of surgery and 30 days after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range is 20 to 80 years old
- •degenerative spine conditions
- •visit at Seoul National University Hospital only
- •Patients who voluntarily consent to participate in the study
排除标准
- •History of surgery around the airway or mediastinum
- •patients with vocal cord-related disorders
- •Patients with fractures, bleeding, or other trauma
- •Patients with neuromuscular diseases, Parkinson's disease, or psychiatric disorders
- •Patients who cannot be extubated or who are transferred to the ICU after surgery
- •Pregnant women
- •Patients who do not wish to participate in the study
结局指标
主要结局
the primary outcome was to measure the incidence of hoarseness
时间窗: voice recordings six hours after the end of anesthesia
the primary outcome was to measure the incidence of voice disorders by conducting Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scoring and voice recordings six hours after the end of anesthesia
次要结局
- The secondary outcome involved measuring the incidence of hoarseness one month after the surgery(one month after the surgery)
研究者
Chun Kee Chung
Clinical Professor
Seoul National University Hospital