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临床试验/NCT02671877
NCT02671877Unknown不适用

Preoperative Fibroscopy as a Predictor of the Difficulty of Laryngoscopy and Intubation

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Difficulty of tracheal intubation

研究概览

简要总结

The aim of this study is the evaluation of preoperative transnasal fiberoscopy, as a possible predictor of difficult laryngoscopy and intubation during elective general anesthesia in an adult population.

Transnasal fibercoscopy is a minimally invasive examination and is routinely performed during ENT evaluation; on the other hand, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific, and an unexpected difficult or failed intubation at the induction of general anesthesia is a seriuos, and potentially fatal, emergency in anesthesia.

In literature, a correlation between anatomical and functional parameters highlighted by fiberoscopy and difficulty of laryngoscopy and intubation has never been demonstrated nor indagated.

If proven, this might give the Anesthestiologist further information about the expected difficulty of laryngoscopy and intubation, guiding a different - and hopefully safer - anesthesiological strategy.

详细描述

This is a prospective, single-center, observational study. Aim of this study is the evaluation of preoperative transnasal fiberoscopy as a predictor of difficult laryngoscopy and intubation during elective general anesthesia in an adult population. Unexpected difficult of failed intubation is a serious, and potentially fatal, occurrence at the induction of general anesthesia. However, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific.

Patients undergoing a scheduled ENT (Ear-Nose-Throat) surgical intervention are subjected to a transnasal fibescopy, a minimally invasive examination, as a part of a normal ENT evaluation before surgery, according to the guidelines of the recruiting center.

During fiberoscopy, the investigators are collecting many anatomical and functional data about the upper airways of the patient. These data include the collapse of the upper airway during the Muller maneuver, the Cormack - Lehane scale as seen in fiberoscopy, the anatomy of the glottis and epiglottis.

The investigators are also collecting data about the preoperative evaluation made by the Anesthesiologist as well as the effective difficulty of laryngoscopy and intubation encountered at the induction of general anaesthesia, expressed by the Cormack - Lehane scale and the Intubation Difficulty Scale (IDS) as described in literature.

General anesthesia will be performed as usual and will not be influenced by fiberoptic evaluation as the Anesthesiologist will be blind to it, and he/she will be free to choose the best anesthesiological plan for his/her patient; whether an elective awake intubation will be chosen, this will exclude the patient from the study.

研究设计

研究类型
Observational
观察模型
Other
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

  • Candidate to elective ENT surgery under general anesthesia

排除标准

  • Subjects with suspect or ascertained malignancy of the nose, mouth, phayrx, or larynx that may interfere with tracheal intubation
  • Subjects with tracheostomy
  • Subjects with active bleeding or waiting for ENT surgery of bleeding lesions
  • Subjects candidate to elective awake intubation

结局指标

主要结局

Difficulty of tracheal intubation

时间窗: Intraoperative (single assessment)

The difficulty of intubation is described with and the Intubation Difficulty Scale (IDS).

次要结局

  • Difficulty of tracheal laryngoscopy(Intraoperative (single assessment))

研究者

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

Marco Gemma

Professor, MD

IRCCS San Raffaele

研究点 (1)

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