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临床试验/NCT06011967
NCT06011967已完成不适用

Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope; Evaluation of the Effect on Post-operative Sore Throat, Ease and Time of Intubation, Hoarseness, Subglottic Damage and Hemodynamic Changes : a Prospective Randomized Study

Yeditepe University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
sore throat

研究概览

简要总结

In this study we compared post-operative sore throat, ease and time of intubation, hoarseness, subglottic damage and hemodynamic changes to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.

详细描述

In this study we compared the ease of intubation, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade. After the approval of the Ethics Committee, patients were randomized into three groups with closed envelope technique. In Group A endotracheal tube (ETT) is shaped into an angel of 90 degrees, in Group B 80 degrees and in Group C 60 degrees with three different stylets. Laryngoscopy was performed using D-Blade in all 3 groups. Heart rate and blood pressure before and after intubation, time from the entrance of the laryngoscope into the mouth to the passage of the vocal cords, time from the appearance of the cords to intubation, Cormack-Lehane (C-L) classification were recorded. Subglottic damage was examined with fiberoptic bronchoscope. Patients were evaluated regarding postoperative sore throat and hoarsness at 30 minutes, 4, 12, 24 hours postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA score I-II
  • Elective operations
  • Supine pozition
  • 18-65 years
  • No history of surgery in the last 6 months
  • No history of airway related surgery
  • No anticipated difficult airway

排除标准

  • Abdomen, thorax, head-neck surgeries
  • Chronic alcohol abuse
  • Occupational inhaler agent exposure
  • Patients with malignancies
  • Patients with a history of radiotheraphy to head-neck region
  • Patients with congenital anomalies at head-neck region
  • Patients with diagnosed abnormalites of head -neck movements
  • Non-cooperatied patients
  • Non-oriented patients

结局指标

主要结局

sore throat

时间窗: 30 minutes, 4 hour, 12 hour, 24 hour

For evaluation of sore throat, the patients were asked whether they had any throat pain. The severity of sore throat was graded as follows: 1: no sore throat, 2: minimal, 3: moderate, 4: severe

次要结局

  • Ease of intubation(2 minutes)
  • Subglottic damage(2 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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