跳至主要内容
临床试验/NCT02847780
NCT02847780已完成不适用

Assessment of Vocal Cord Movement After Thyroid Surgery Using C-MAC Video-laryngoscope and Airway Ultrasound.

Rajiv Gandhi Cancer Institute & Research Center, India2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
• To determine objective vocal cord mobility by the video laryngoscope and airway ultrasound

研究概览

简要总结

This study is planned to compare C-Mac video-laryngoscope and airway ultrasound as two novel techniques (causing least discomfort to the patients) for the detection of impaired vocal-cord movement after thyroid surgery.

详细描述

In this prospective study 100 patients posted for Thyroid surgery will be included, after explaining the procedure and written informed consent, all included patients in the study will be assessed for vocal cord mobility by C-Mac video laryngoscope (manufactured by KARL STORZ Video Laryngoscopes) followed by airway ultrasonography (USG). Linear transducer (7.5 MHz) will be used for scanning the airway placed at the level of thyroid cartilage with 10-15 degree cephalad tilt so to get proper acoustic window and for optimal visualization of laryngeal structures. C-Mac video laryngoscope will be required for virtual visualization of glottis apertures and vocal cord movement. All patients will be scanned pre-operatively by indirect laryngoscopy to see vocal cord mobility as a reference value. Immediately after extubation the patient will be scanned for vocal cord mobility by videolaryngoscope by first examiner, After oxygenation and stabilization of haemodynamic, ultrasound of airway will be performed to study the vocal cord movement by the other examiner (blinded to the laryngoscopy finding).Visibility of false vocal cords, true vocal cords and arytenoids will be given one point each for one side, maximal score will be 6. According to points the acoustic window scoring for glottis aperture will be graded as fair (score1-2), good(score3-4) and very good(score5-6) Findings of both the examiners will be collected by the primary investigator for data collection and analysis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Care Provider)

入排标准

年龄范围
17 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient's undergoing thyroid and parathyroid surgery.

排除标准

  • patients not extubated.

结局指标

主要结局

• To determine objective vocal cord mobility by the video laryngoscope and airway ultrasound

时间窗: At time of extubation.

patients vocal cords will be assessed by videolaryngoscope at time of extubation then the cords will be again assessed by airway ultrasound.

次要结局

  • • To ascertain whether airway ultrasound can be used as a reliable alternative to assess post-operative vocal cord mobility(After extubation and before dressing.)

研究者

发起方
Rajiv Gandhi Cancer Institute & Research Center, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amit Kumar Mittal

Consultant in-charge

Rajiv Gandhi Cancer Institute & Research Center, India

研究点 (2)

Loading locations...

相似试验

Comparison of Two Technique for Assessment of Vocal... | 临床试验