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临床试验/NCT01491984
NCT01491984已完成4 期

Effectiveness and Safety of the Levitan FPS Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway in Surgical Subjects Under General Anesthesia

IWK Health Centre0 个研究点目标入组 105 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
105
主要终点
Cormack-Lehane Grade

研究概览

简要总结

A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation.

详细描述

A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation. The placement of a breathing tube into the windpipe is a skill that is not easily mastered. In fact, the placement is difficult or impossible using the usual technique in 1-3 of every 100 patients. The ease of placing this breathing tube depends in part on how easily and how much of the vocal cords are able to be seen directly using a laryngoscope.

In a small number of patients, the Levitan First Pass Success (FPS) Scope has been shown to be more effective and easier to insert even in patients who have difficult airways. This study will evaluate the use of the LFS compared to the other conventional laryngoscope in subjects with a simulated difficult airway. The goal of this study is to determine the effectiveness and safety of the LFS in a large number of patients with simulated airway difficulties.

The results obtained during the study may provide useful information to health care providers who cannot place a breathing tube in patients that are either in operating rooms or in emergency situations requiring intubation by paramedics. An example would be a trauma situation where a paramedic is having difficulty attempting an intubation when a patients c-spine is being protected from any movements.

The LFS is an affordable and transportable device, which makes this an attractive asset for health providers in smaller community settings or in paramedic vehicles which may not have the capacity to stock or ability to afford a variety of different scopes and must choose a more limited selection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild systemic disease, ex. asthma, high blood pressure)
  • Elective surgery requiring endotracheal intubation
  • English speaking
  • Age 16 - 75 years

排除标准

  • Significant gastroesophageal reflux disease (GERD) that may require alternate induction/intubation techniques
  • Prior history of a difficult intubation requiring an awake tracheal intubation
  • Clinical predictors of a potentially difficult intubation requiring an awake intubation
  • BMI > 45 kg/m2 (Obesity is a common and important risk factor for difficult intubation)

结局指标

主要结局

Cormack-Lehane Grade

时间窗: intraoperative

The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale. Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen

次要结局

  • Number of Intubation Attempts(intraoperative)
  • Time to Successful Intubation(intraoperative)
  • Operator Rating of Difficulty(intraoperative)

研究者

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

Ronald George

Primary Investigator, MD, FRCPC, Assistant Professor

IWK Health Centre

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