跳至主要内容
临床试验/NCT01630694
NCT01630694终止不适用

Three -Dimensional (3-D) Craniofacial Phenotyping of Patients With Difficult Airway

University of Rochester2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
28
试验地点
2
主要终点
Mean Hyomental Distance Ratio

研究概览

简要总结

The purpose of this study is to identify differences in craniofacial morphology and tongue size between patients who have a history of difficult airway management and a control group of patients who had an uneventful airway management during induction of general anesthesia. In this study the investigators want to validate the hypothesis that there are craniofacial phenotypic differences between patients who have a history of difficult airway management and a control group of patients who have had an uneventful airway management during the induction of general anesthesia.

详细描述

Difficult airway management is one of the most challenging tasks for anesthesiologists. Recent data from the American Society of Anesthesiologists (ASA) Management Closed Claims Project [1] show that the percentage of claims resulting from adverse respiratory events, though on the decline (42% in the 1980s to 32% in the 1990s), continue to constitute a large source of morbidity and mortality in anesthetized patients. In 2005, a closed claims analysis of trends in anesthesia-related death and brain damage between 1975 and 2000 showed that out of all respiratory events (n=503) responsible for death and brain damage, difficult endotracheal intubation (n=115), inadequate oxygenation (n=111) and inadvertent esophageal intubation (n=66) were the top three causes [2].

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients that had undergone or will undergo a surgery under general anesthesia .

排除标准

  • known history of syndromal craniofacial abnormalities (e.g. Down syndrome)
  • previous craniofacial surgery
  • excessive facial hair which significantly obscure facial landmarks
  • cervical spine fractures
  • tracheostomy tube
  • patients who are unable to give consent

结局指标

主要结局

Mean Hyomental Distance Ratio

时间窗: end of study approximately one year

A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.

次要结局

  • Mean Tongue Volume(end of study approximately one year)

研究者

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

Jacek Wojtczak

Principal investigator

University of Rochester

研究点 (2)

Loading locations...

相似试验