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临床试验/CTRI/2018/05/014284
CTRI/2018/05/014284已完成不适用

A comparative study between the Macintosh laryngoscope and Airtraq video laryngoscope in thyroid swellings for endotracheal intubation

Pratibha singh1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年1月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
time taken in successful intubation

研究概览

简要总结

According to Americal Society of Anaesthesiologists (ASA), difficult airway is the clinical situation in which a conventionally trained anaesthesiologist experiences difficulty with mask ventillation, difficulty with tracheal intubation, or both.

ASA defines difficult endotracheal intubation as proper insertion of the tracheal tube with conventional laryngoscopy requires more than three attempts or more than 10 minutes.

Operating room cases involving the removal of goiters falls within the difficult airway classificaton. Goiters often involve a number of anatomical locations and results in many implications to the airway and vascular structures. This can lead to upper and lowerairway obstruction, laryngeal malacia, lymphatic and vascular congestion causing edemathat will further compromise the patient’s airway.

Keeping in view the difficult airway due to enlarged thyroid swelling, the present study is being done as comparative study between Macintosh laryngoscope and Airtraq video laryngocscope for thyroid swelling has not been done so far.

patients will be divided randomly into two groups. preoperatively proper airway assessment and complete systemic examination will be done. written and explained consent will be taken. patients in both groups will be given Fentanyl at 2mcg/kg body weight before induction and will be induced with Propofol at 2mg/kg body weight. after checking for bag and mask ventillation succinylcholine will be given at 2mg/kg body weight. after 1 min of ventillation patient will be intubated with any of the two mentioned methods with an armoured endotracheal tube of appropriate size. then the assessment will be made regarding:

  1. time of successful intubation

  2. ease of intubation

  3. percentage of glottic opening

  4. modified Cormack and Lehane grading

  5.  change in vitals

  6. post operative upper airway symptoms

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA grade 1 or 2 Mallampatti score 1 or 2.

排除标准

  • patient not giving informed consent history of previous neck surgery history of difficult intubation in any previous surgey interincisor distance less than 3cm ASA grade > 2 MPG score 3 or 4.

结局指标

主要结局

time taken in successful intubation

时间窗: in seconds

次要结局

  • ease of intubation(by intubation difficulty score)
  • percentage of glottic opening(POGO score)
  • modified Cormack and Lehane grading(1-4)
  • change in vitals(heart rate (in beats/min), BP(in mm of Hg) and SpO2(in %))
  • post operative upper airway symptoms(throat pain and hoarseness of voice)

研究者

发起方
Pratibha singh
申办方类型
Other [[self]]

研究点 (1)

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