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临床试验/NCT02957084
NCT02957084已完成不适用

Anatomic Features of the Neck and Preoperative Tests as Predictive Markers of Difficult Direct Laryngoscopy

National and Kapodistrian University of Athens0 个研究点目标入组 1,142 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,142
主要终点
Difficult laryngoscopy classification using Cormack-Lehane Grade

研究概览

简要总结

In this prospective, open cohort study the diagnostic value of tests based on neck anatomy in predicting difficult laryngoscopy was assessed.

The anatomic features of the neck measured were head extension, mouth opening, upper lip bite, Mallampati class, thyromental distance, sternomental distance, ratio of height to thyromental, neck circumference, thyrosternal distance, hyomental distance at full head extension (FHE) and at neutral position (NP), ratio of neck circumference to thyromental distance and ratio of hyomental distance FHE to hyomental distance NP.

详细描述

Difficult airway assessment is based on various anatomic parameters of upper airway, much of it being concentrated on oral cavity and the pharyngeal structures. The diagnostic value of tests based on neck anatomy in predicting difficult laryngoscopy was assessed in this study .

The sample consisted of adult patients scheduled to receive general anaesthesia. Anatomic features of the neck were measured pre-operatively.

The anatomic features of the neck measured were thyromental distance, sternomental distance, ratio of height to thyromental, neck circumference, thyrosternal distance, hyomental distance at full head extension (FHE) and at neutral position (NP), ratio of neck circumference to thyromental distance and ratio of hyomental distance FHE to hyomental distance NP. The commonly used predictive tests head extension, mouth opening, upper lip bite test and Mallampati class were also measured.

The laryngoscopic view was classified according to the Cormack-Lehane Grade (1-4). Difficult laryngoscopy was defined as Cormack-Lehane Grade 3 or 4. Years of experience of the anaesthesiologists were recorded, as well as the number of tries needed to intubate the patient.

The optimal cut-off points for each predictive tests were identified by using receiver operating characteristic analysis. Sensitivity, specificity and positive predictive value and negative predictive value (NPV) were calculated for each test. Multivariate analysis with logistic regression, including all variables, was used to create a predictive model. Comparisons between genders were also performed to explore possible differences in diagnostic value and cut-off points. Finally, the years of experience of the clinician and the number of tries needed to intubate the patient were compared to assess risk of bias.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adult patients
  • BMI less than 35 kg/m2
  • No known neck or airway pathology
  • Scheduled for surgical procedures under general anaesthesia with tracheal intubation

排除标准

  • Age less than 18 years
  • BMI higher than 35 kg/m2
  • Obvious airway malformations
  • Need for rapid sequence induction/intubation under cricoid pressure
  • Awake intubation
  • Cervical spine pathology requiring specific manipulation
  • Obstetric cases

结局指标

主要结局

Difficult laryngoscopy classification using Cormack-Lehane Grade

时间窗: immediate

Assessment of difficult laryngoscopy at the time of the airway management procedure. Classified as Grade I - visualization of entire laryngeal aperture, grade II - visualization of only posterior commissure of laryngeal aperture, grade III - visualization of only epiglottis, grade IV - visualization of just the soft palate.

次要结局

  • Thyromental distance measured in cm with a measuring tape(immediate)
  • Thyrosternal distance calculated in cm(immediate)
  • Upper lip bite test(immediate)
  • Head extension measured in degrees with goniometer(immediate)
  • Ratio of neck circumference to thyromental distance(immediate)
  • Hyomental distance at full head extension (FHE) measured in cm with a measuring tape(immediate)
  • Hyomental distance at neutral position (NP) measured in cm with a measuring tape(immediate)
  • Ratio of hyomental distance at FHE to hyomental distance at NP(immediate)
  • Mallampati class(immediate)
  • Neck circumference measured in cm with a measuring tape(immediate)
  • Sternomental distance measured in cm with a measuring tape(immediate)
  • Ratio of height to thyromental distance(immediate)
  • Mouth opening measured in cm with a measuring tape(immediate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chara Liaskou

RN, Msc, Phd(c)

National and Kapodistrian University of Athens

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