跳至主要内容
临床试验/NCT03502590
NCT03502590招募中不适用

Effectiveness of Airway Control Using the IGEL Laryngeal Mask Airway Device in Patients With Previous Radiotherapy to the Neck

NHS Lothian1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
NHS Lothian
入组人数
62
试验地点
1
主要终点
Successful insertion of the device and ventilation of the patient

研究概览

简要总结

It is known that patients with head and neck cancer who have had radiation therapy to the structures of the neck are at a greater risk of difficult mask ventilation and tracheal intubation than the majority of patients undergoing general anaesthesia.

Failure to maintain oxygenation can lead to catastrophic consequences for any patient undergoing general anaesthesia, such as severe hypoxic brain injury and death.

As such, the current guidelines from the Difficult Airway Society promote the use of a second generation laryngeal mask airway to maintain oxygenation in the event of failed mask ventilation or tracheal intubation, a rescue technique that has in most patient groups a very high chance of success. Unfortunately these guidelines are by necessity generic guidance and do not take into account the clinical performance of these devices in specific patient groups. While there is evidence of the effectiveness of the IGEL device as the primary method of airway maintenance in many studies there are none that describe its clinical performance in a group of patients in whom the rate of failed mask ventilation and tracheal intubation are significantly higher than the general population of patients. It is therefore of great interest to have an idea of the likelihood of success of rescue ventilation with this device in a group of high risk patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • 18 years or older
  • Attending for an elective procedure requiring general anaesthesia
  • Prior radiotherapy to the neck

排除标准

  • General anaesthesia is not the primary airway plan
  • Previously known difficult intubation
  • Patient refusal

研究组 & 干预措施

IGEL arm

Experimental

Placement of a physician decided IGEl airway device in patients with prior radiotherapy to the neck to assess adequacy of ventilation

干预措施: IGEL Laryngeal mask (Device)

结局指标

主要结局

Successful insertion of the device and ventilation of the patient

时间窗: 10 minutes

Time to successful ventilation as evidenced by 5 consecutive square wave end tidal carbon dioxide waveforms.

次要结局

未报告次要终点

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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