跳至主要内容
临床试验/CTRI/2020/03/024324
CTRI/2020/03/024324尚未招募不适用

Ultrasound guided evaluation of airway in predicting difficult endotracheal intubation in an eastern Indian Hospital

Tata Main Hospital1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2020年3月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
174
试验地点
1
主要终点
To find out the sensitivity, specificity, positive predictive value and negative predictive value of ultrasonographic airway assessment parameters; Skin soft tissue thickness at level of Hyoid bone, Skin soft tissue thickness at level of vocal cords, distance from skin to epiglottis midway and ratio of the depth of the Pre-Epiglottic space to the distance from the epiglottis to the mid-point of the distance between the vocal cords (E-VC) for predicting a difficult airway.

研究概览

简要总结

Several pre-operative airway assessment methods exist to predict difficult airway, but unexpected difficult endotracheal intubation may occur. These assessment criteria are not often useful in uncooperative patients and unconscious patients.  Most of the airway assessment criteria are objective in nature and are therefore prone to inter-observer variability. Also, the Cormack Lehane grading doesn’t always correlate with pre-op airway assessment parameters. Hence, the diagnostic accuracy by the pre-operative assessment technique remains inadequate for predicting difficult endotracheal intubation and there is still search for a simple, yet non-invasive way to provide more accurate prediction  about difficult airway. There are limited literature available comparing airway ultrasound parameters with difficult airway scoring system based on observation using direct laryngoscopy. Besides that, there is no available literature regarding ultrasonographic soft tissue thickness parameters of neck as a part of preoperative airway assessment in patients admitted to an Eastern Indian hospital. Therefore present study has been taken up to determine utility of ultrasound based airway assessment in evaluating difficult airway in patients admitted to an eastern Indian hospital.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of ASA Grade I to II
  • Patients undergoing surgery requiring General Anaesthesia with endotracheal intubation.

排除标准

  • Patients requiring rapid sequence endotracheal intubation.
  • Patients with cervical spine pathology
  • Patients with head and neck pathology,large thyroid swelling
  • Uncooperative patients.

结局指标

主要结局

To find out the sensitivity, specificity, positive predictive value and negative predictive value of ultrasonographic airway assessment parameters; Skin soft tissue thickness at level of Hyoid bone, Skin soft tissue thickness at level of vocal cords, distance from skin to epiglottis midway and ratio of the depth of the Pre-Epiglottic space to the distance from the epiglottis to the mid-point of the distance between the vocal cords (E-VC) for predicting a difficult airway.

时间窗: 1.ULtrasound examination of airway will be done before endotracheal intubation | 2. Intubation Difficulty score (IDS) assessment will be done during laryngoscopy and intubation

次要结局

  • To develop a scoring system for ultrasonographic airway assessment parameters, which best predicts a difficult airway.(Scoring system will be developed after analysis of data of all recruited patients)

研究者

申办方类型
Other [Industrial Hospital]

研究点 (1)

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