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临床试验/NCT01032460
NCT01032460
已完成
不适用

Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.

University College Hospital Galway1 个研究点 分布在 1 个国家目标入组 90 人2010年1月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Immobilization
发起方
University College Hospital Galway
入组人数
90
试验地点
1
主要终点
Rate of successful placement of Tube in the Trachea a. Failed intubation defined as requiring greater than 60s or which resulted in Oesophageal Intubation. b. Successful intubation confirmed by an investigator.
状态
已完成
最后更新
15年前

概览

简要总结

It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where the neck is immobilized.

The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.

These devices may be especially effective in situations where intubation of the trachea is potentially difficult.

The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in situations where the cervical spine is immobilized is not known.

The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC to that of the Macintosh laryngoscope, the gold standard device, in patients in which the cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.

Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh laryngoscope in simulated difficult laryngoscopy.

注册库
clinicaltrials.gov
开始日期
2010年1月
结束日期
2010年11月
最后更新
15年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
University College Hospital Galway

入排标准

入选标准

  • ASA 1 - 3
  • Aged 18 - 85 years
  • Written informed Consent
  • No relevant drug allergies
  • Mallampatti 1 - 2.

排除标准

  • Patients unable to cooperate with airway assessment (2)
  • Patients with predicted difficult intubation
  • Mallampatti III or IV
  • Thyromental distance \< 6cm
  • Mouth opening \< 3.5 cm
  • Cervical spine disease
  • Anteriorly protruding incisors
  • Poor Dentition (2)
  • Tumours, polyps or foreign bodies in the upper airway (2)
  • Patients with documented difficult airways (2).

结局指标

主要结局

Rate of successful placement of Tube in the Trachea a. Failed intubation defined as requiring greater than 60s or which resulted in Oesophageal Intubation. b. Successful intubation confirmed by an investigator.

时间窗: immediately

次要结局

  • Duration of Intubation attempt (successful Attempts only) a. Absolute time taken to perform successful tracheal intubation b. Number of successful intubations completed within 30 seconds.(immediatley)
  • Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt(immediately)
  • Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score(immediately)
  • Intubation Difficulty Scale score(immediately)
  • Need for and number of optimisation Manoeuvres to aid tracheal intubation(immediately)

研究点 (1)

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