To compare the efficacy of Transcutaneous Laryngeal Ultrasonography (TLUSG) and Direct Laryngoscopy in assessing the function of vocal cords postoperatively in Thyroidectomy patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess of vocal cords by both laryngeal ultrasonography and direct laryngoscopy in compare which modality is better and provides good patient comfort in Thyroidectomy patients
研究概览
简要总结
Vocal cord paresis or palsy caused as a result of recurrent laryngeal nerve injury is a complication of disquietude as it can also be a mainspring of medicolegal litigation. Hence the preservation of recurrent laryngeal nerve (RLN) becomes the most importa nt part of thyroid surgery. The incidence of recurrent laryngeal nerve injury varies, ranging from 0.4% to 7.2% for temporary paresis and from 0% to 5.2% for permanent paralysis
Commonly pati ents undergoing thyroidectomy are evaluated for postoperative recurrent laryngeal nerve function for vocal cord mobility with indirect laryngoscopy.The practice of examining the vocal cords in the immediate postoperative period just after the extubation for the presence of any vocal cord dysfunction is advocated by many surgeons. But, in two settings patients are exposed to unnecessary laryngoscopic examinations which often cause discomfort to the patient.Tran scutaneous ultrasound (USG) is a cheap, noninvasive substitute to the above methods for examining the patients to assess the vocal cord function routinely for elective Thyroidectomy both preoperatively and postoperatively.Wong KP, et al. conducted a study in which 204 patients underwent TLUSG and direct laryngoscopy before and after elective thyroidectomy. For both examinations, vocal cord movements were independently graded. To assess accuracy, TLUSG findings were correlated with direct l aryngoscopy findings. Postoperative TLUSG had a sensitivity, specificity, positive predictive value, and negative predictive value of 93.3%, 97.8%, 77.8%, and 99.4%, respectively.
STUDY DESIGN
Type of study : Prospective Observational Cohort Study. Sample size and sampling methods : ee written informed consent will be The study of Wong KP, et al observed that sensitivity and specificity of TLUSG in di agnosing VCP were 93.3%, 97.8% respectively.(
Taking these values as reference, the minimum required sample size with desired precision of 15%, 80%power of study and5% level of significance is 32 patients. To reduce margin of error, total sample size taken is 40.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA physical status I and II of either sex 2.Age between 18-65 years 3.Scheduled for thyroid surgeries under general anaesthesia.
排除标准
- •Patients belonging to asa IV
- •Pre-existing neurological disease affecting vocal cords
- •Patient with limited neck extension 4.patients with previous neck surgeries.
结局指标
主要结局
To assess of vocal cords by both laryngeal ultrasonography and direct laryngoscopy in compare which modality is better and provides good patient comfort in Thyroidectomy patients
时间窗: Opd vist - indirect laryngoscopy or laryngo endoscopy Preoperatively 30 minutes before induction of Anesthesia Laryngeal ultrasound by Anesthesiologist 10minutes before extubation direct Laryngoscopy and assesment of vocal colds | In first hour of postoperative period by 2nd Laryngeal ultrasound by different anesthesiologist followed by 5 days on the day of discharge indirect laryngoscopy
次要结局
- To evaluate the heamodynamic parameters and patients comfort while assseing the vocal cords using both methods(Blood pressure,heart rate,spo2, respiratory rate and mean arterial pressure are assesed before extubation and also noted at 1 min 2min 3 min 4 min 5 min during directlarunhiscopy)