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临床试验/NCT02981511
NCT02981511Unknown不适用

Assessing the Potential Use of Optiflow as a Preoxygenation Method Prior to Anaesthesia.

University Hospital Southampton NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
time to end tidal oxygen content of 0.85

研究概览

简要总结

Optiflow can be used to prolong the apnoea period under anaesthesia without falls in blood oxygen saturation. This study is designed to assess whether the Optiflow system can efficiently replace conventional anaesthetic mask and circuit preoxygenation so that it could be used in emergency anaesthesia. If so, it would be then be in place in the case of difficult or failed intubation to maintain oxygenation ie: it could preoxygenate and then maintain oxygenation seamlessly.

详细描述

The Optiflow device is used to deliver high flow humidified oxygen/air via nasal cannulae to patients who have respiratory problems. More recently it has been used in patients having surgery on their larynx who are intentionally paralysed under anaesthesia where the surgeon does not want any tubes in the airway. This makes access for surgery easier/possible. Perhaps surprisingly, these patients can be left apnoeic for 30 minutes without falls in blood oxygen levels. The lungs are oxygenated despite there being no in and out breathing/ventilation.

We propose that applying Optiflow at the start of an emergency anaesthetic may be beneficial when an anaesthetist finds that tracheal intubation is impossible - a "failed intubation" scenario. Optiflow might maintain oxygenation during further attempts at intubation or until more skilled anaesthetists arrive.

Another alternative technique presently in common use is for the patient to breathe 100% oxygen via a facemask and conventional anaesthetic circuit for 3 minutes before anaesthesia starts (preoxygenation). This fills the functional residual capacity of the lungs to about 90% oxygen giving an oxygen reserve when the breathing stops until the anaesthetist breathes for them after intubating the trachea. This can result in the maintenance of normal blood oxygen saturation for several minutes longer than would be the case if the lungs had only been exposed to air before anaesthesia.

The research question that we ask is whether we can just use Optiflow instead of the conventional mask/circuit to preoxygenate patients to a similar extent and as quickly as using a facemask so that, in emergency surgery, Optiflow could be used to preoxygenate and then already be in place in case there is a failed intubation. This would enable Optiflow to be used for both purposes seamlessly without the need to switch between the two methods of oxygenation.

Research to date has not yet identified how long Optiflow needs to be in place before anaesthesia for it to be able to produce adequate preoxygenation of the lungs before the patient stops breathing. The 3 minute timing for preoxygenation is important in emergency cases e.g. when there is an emergency caesarean section to be done and every minute before the baby is delivered matters. If it were not possible to preoxygenate a patient's lungs within 3 minutes using Optiflow we would suggest that it is inappropriate to replace conventional mask pre-oxygenation and that its value in emergency anaesthesia might be reduced (although it may still have potential for less urgent anaesthesia when it could be applied for a longer duration before anaesthesia).

研究设计

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

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy (ASA1or 2)

排除标准

  • respiratory disease

结局指标

主要结局

time to end tidal oxygen content of 0.85

时间窗: less than 10 minutes

time to this end point will be found by up/down sequential tests

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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