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临床试验/NCT01064908
NCT01064908已完成不适用

A Study To Determine The Effectiveness Of A New Oxygen Mask At Increasing Arterial Oxygen Content During Carotid Endarterectomy Under Local Anaesthesia

Brighton and Sussex University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
The primary aim of this study the aim is to determine the effectiveness of the vortex oxygen mask in increasing blood oxygen levels during CEA in the awake patient during carotid clamping.

研究概览

简要总结

The purpose of this study is to determine the effectiveness of oxygenation and patient-acceptability of a novel oxygen face mask in patients undergoing carotid endarterectomies (CEAs).

详细描述

Carotid endarterectomy (CEA) is a procedure to remove plaques from a carotid artery (one of the two main arteries supplying blood to the brain). The procedure is effective at reducing the risk of subsequent stroke. To access the artery, an incision is made in the artery wall which means that the artery must be clamped in order to prevent blood loss. Consequently, the blood supply (and therefore oxygen supply) to the brain is reduced. To ensure that the patient has sufficient oxygen to avoid brain damage, this procedure is often carried out under local anaesthetic as this means the anaesthetist can talk to them during the operation; by this means they can determine the patient's conscious level and whether or not they need supplementary oxygen.

There are various ways to administer the supplementary oxygen. Most oxygen masks completely cover the mouth and nose which inevitably limits patient-doctor communication. Oxygen is therefore usually administered via nasal tubes. However, the actual level of oxygen taken in by the patient is very hard to measure, and at best is only 40%.

A novel mask with an open design. By creating a 'vortex' of oxygen it can deliver higher concentrations of oxygen to the patient without significantly interfering with doctor-patient communication and, at the same time, improving patient comfort.

We wish to test the efficacy of this mask during CEA and plan to do this by measuring the oxygen content of blood directly using blood samples; we also monitor markers of brain damage which may occur from lack of oxygen. Finally, we will survey the patients as to acceptability of the mask.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Male or female
  • Booked for carotid endarterectomy under local anaesthetic
  • Competent to consent to inclusion

排除标准

  • Patient refusal and inability to provide consent
  • Patients who are unable to understand instruction or communicate effectively
  • Aged below 16 years
  • Decreased conscious level during the period of study

结局指标

主要结局

The primary aim of this study the aim is to determine the effectiveness of the vortex oxygen mask in increasing blood oxygen levels during CEA in the awake patient during carotid clamping.

时间窗: 0 hours

次要结局

  • To determine whether or not increased cerebral oxygen levels are associated with reduced cerebral injury, as measured by biomarkers: neuron-specific enolase and S100B.(2.5 hours.)
  • A further secondary outcome is to determine whether the mask is acceptable to patients, as recorded by a questionnaire.(Within 24 hours post-operatively)

研究者

发起方
Brighton and Sussex University Hospitals NHS Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr C. Mark Harper

Consultant Anaesthetist

Brighton and Sussex University Hospitals NHS Trust

研究点 (1)

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