The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day
研究概览
简要总结
Population-based single centre, blinded, prospective cohort study of the impact of recurrent laryngeal nerve (RLN) injury on Thoracic Surgery patients. The principal outcome of interest is the effect of RLN injury on respiratory complications. Voice, swallowing, cardiac and mortality outcomes will also be determined.
详细描述
Objectives:
Primary: Estimate the prevalence of vocal cord dysfunction after thoracic surgery and the association of vocal cord dysfunction and immediate post operative respiratory complication after thoracic surgery.
Secondary:
- Estimate the prevalence of vocal cord dysfunction in the pre-operative patient population undergoing thoracic surgery, i.e. the baseline prevalence.
- Estimate the incidence of new vocal cord dysfunction in the post-operative period, i.e. the incidence of new dysfunction
- Estimate the association of vocal cord dysfunction and respiratory, voice, swallowing, and mortality outcomes
- Estimate the impact of vocal cord immobility on hospital length of stay, ICU admission rates and duration
Population: All patients undergoing thoracic surgery at Health Sciences Centre in Winnipeg, Canada. This is a tertiary care centre with a population-based referral base of 1.5 million people
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing thoracic surgery at Health Sciences Centre Winnipeg. Recruitment will be performed by the thoracic surgeon faculty within the Division of Thoracic Surgery. Written informed consent will be obtained from the patient by an independent research assistant.
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provide signed and dated informed consent form.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Male or female, aged 18 and over..
- •Have a condition requiring surgical entry into the thoracic cavity
排除标准
- •All individuals meeting any of the exclusion criteria at baseline will be excluded from the study. Patients with severely deviated nasal anatomy precluding flexible nasolaryngoscopy Tracheostomy in situ Neurologic or developmental deficits impairing the ability to consent or cooperate with examination
结局指标
主要结局
Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day
时间窗: Post-operative day 1
次要结局
- Number of patients with respiratory complictions(Within 30 days of operation)
- Hospital length of stay(From date of primary operation to discharge)
- Readmission to hospital(From day of surgery to day 90 after operation)
- Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy prior to operation(Day of operation)
- The number of patients with swallowing difficulties, cardiac complications and who have died(From the date of operation to day 30 after operation)
- ICU length of stay(From date of operation to discharge from hospital)
研究者
Sadeesh Srinathan, MD
Dr. Sadeesh Srinathan Associate Professor Section of Thoracic Surgery
University of Manitoba