Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Predictive performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound: conventional middle approach compared to lateral approach
研究概览
简要总结
• Anterior cervical discectomy and fusion (ACDF) is a highly effective and safe method for spinal cord and cervical root decompression. Vocal cord paralysis secondary to recurrent laryngeal nerve injury is a common complication after ACDF. The incidence reported as high as 22%. The standard technique for vocal cord evaluation and the most commonly used tool is direct laryngoscopy. Laryngoscopy causes patients annoyance and could potentially contribute to poor patient compliance. Ultrasonography is a non-invasive technique that is used as an alternative tool.
详细描述
- Design: A prospective cohort study.
- Sample size: Assuming that the target population is 240 and positive predictive value of transcutaneous laryngeal ultrasonography is 89.4%. So, the sample size is 91 cases using OPEN Source Epidemiologic Statistics for Public Health (OPENEPI) with confidence interval 95% and power of test is 80%.
All patients underwent transcutaneous laryngeal ultrasonography examination by both anterior and lateral approach of the Vocal Cords (VCs) before the surgery, immediately after extubation, 2 h, 12h, 24 and 48hour postoperatively by an anesthesiologist with an experience of at least three years in ultrasonography scan.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient acceptance.
- •Age (21-60) years old.
- •American Society of Anesthesiologist I / II
- •Elective anterior cervical spine surgeries
- •patient With Body Mass index (25-35 kg/m²)
排除标准
- •Patient refusal.
- •Altered mental status.
- •Patients with per-existing neurological or thyroid disease affecting vocal cord function.
- •Patients with a diagnosis of primary untreated laryngeal/hypopharyngeal cancer.
- •Patient with a history of thyroidectomy affecting recurrent laryngeal nerve.
- •Patient with a history of laryngeal trauma.
- •Pre-operative voice abnormalities.
结局指标
主要结局
Predictive performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound: conventional middle approach compared to lateral approach
时间窗: at the end of the first 48 hours after the surgery
The predictive performance of postoperative vocal cord edema and paralysis using the conventional middle and lateral approach of trans cutaneous laryngeal ultrasound will be evaluated using sensitivity, specificity and accuracy . the gold standard for diagnosis of vocal cord edema and paralysis will be the rigid laryngoscopy
次要结局
- Diagnostic performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound(At 2 weeks and 3 months after the surgery)
- The patient discomfort to procedure(at the end of first 48 hour postoperative)
研究者
Alshaimaa Abdel Fattah Kamel
lecturer of Anaesthesia ,and surgical intensive care
Zagazig University