跳至主要内容
临床试验/NCT02788253
NCT02788253已完成不适用

Comparison of the Mallampati Classification and Best Visible Mallampati for Prediction of Difficult Tracheal Intubation

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 3,244 人开始时间: 2017年6月1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
3,244
试验地点
1
主要终点
Number of patients with difficult airway management

研究概览

简要总结

Mallampati score (classification of the visibility of oropharyngeal structures) should be performed in the sitting position, head in the neutral position, mouth widely open, and tongue protrudes, without phonation. However, phonation, and position modify the visibility of oropharyngeal structures and thus the Mallampati score.

We aimed at evaluating the predictive value of the best observable Mallampati score as compare to the recommended Mallampati score.

详细描述

Mallampati score (classification of the visibility of oropharyngeal structures) should be performed in the sitting position, head in the neutral position, mouth widely open, and tongue protrudes, without phonation. However, phonation, and position modify the visibility of oropharyngeal structures and thus the Mallampati score.

We aimed at evaluating the predictive value of the best observable Mallampati score as compare to the recommended Mallampati score.

This is a single center prospective observational study comparing the original Mallampati classification to the best visible Mallampati classification.

Data and variables concerning airway management during induction of general anesthesia are recorded on a specific record sheet.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Scheduled or unscheduled surgery
  • •Airway evaluation possible in both sitting and supine position

排除标准

  • •surgery of the neck, face, and upper airway
  • •lung and thoracic surgery
  • •pregnancy
  • •orotracheal intubation not indicated during surgery
  • •nasotracheal intubation required for surgery
  • •selective intubation required for surgery
  • •emergency surgery and procedure

结局指标

主要结局

Number of patients with difficult airway management

时间窗: 1 day

Occurence of either difficult tracheal intubation or difficult face mask ventilation or both Difficult tracheal intubation was defined as an orotracheal intubation requiring more than 2 laryngoscopies, or lasting more than 10 min, or requiring an alternate device (gum elastic bougie, supraglottic device, videolaryngoscope) Difficult mask ventilation was defined as the inability for the anesthesiologist to provide adequate ventilation because of one or more of the following problems: inability for the unassisted anesthesiologists to maintain oxygen saturation \> 92% using 100% oxygen, excessive gas leak requiring use of the oxygen flush valve more than twice, excessive insufflation pressure (\> 25 cmH2O), absence of spirometric measures of exhaled gas flow or a tidal volume \< 3ml/kg, absence or inadequate exhaled carbon dioxide, necessity to perform two-handed mask ventilation

次要结局

  • Number of patients with difficult tracheal intubation(1 day)
  • Number of patient with difficult Face Mask Ventilation(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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