ISRCTN12362720已完成不适用
The Stroke Oxygen Pilot Study: a randomised controlled pilot study of the effects of routine oxygen supplementation on functional outcome after acute stroke
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)0 个研究点目标入组 300 人开始时间: 2005年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Adult patients (either sex) will be eligible for trial inclusion if they were admitted with symptoms of an acute stroke within the preceding 24 h and if, in the doctor's opinion, there is no clear indication for and no clear contraindication against oxygen treatment (added as of 01/05/2008).
- •1. Identification:
- •All patients admitted to the University Hospital of North Staffordshire with an acute stroke will be eligible to be considered for trial inclusion. They will be identified as potential participants by a member of the research team or by staff in the Medical Admissions Unit, Accident and Emergency (A&E), or the Emergency Admission Unit.
- •2. Approach:
- •Potential participants will be approached by a member of the research team or the doctor admitting the patient. Because hypoxia is more likely to be detrimental early after the stroke, when the ischaemic penumbra either recovers or expands it is crucial to include patients as soon as possible after the stroke onset into the trial. Patients will therefore be approached as soon as they enter hospital via the Medical Assessment Unit or the Accident and Emergency department, or at the next earliest opportunity on a medical ward up to 24 hours after admission.
- •3. Recruitment:
- •The study will be explained to potential participants and they will be invited to take part. The patient will then be given an information leaflet. If he/she agrees to take part they will be recruited to the trial after informed consent has been given. If the patient does not disagree, but is incompetent to give fully informed consent, assent will be sought from the next of kin using the same procedure.
排除标准
- •Added as of 01/05/2008:
- •1. Patients who have recognised indications for oxygen treatment such as:
- •1.1. Oxygen saturation on air less than 90%
- •1.2. Hypoxia associated with acute left ventricular failure, severe pneumonia and pulmonary embolus
- •1.3. Chronic respiratory failure treated with long term oxygen at home
- •2. Recognised contra-indications to fixed dose oxygen treatment (2 - 3 l/min/vy nasal tubes): type II respiratory failure (contra-indication to fixed dose oxygen as given in this trial)
- •3. The stroke is not the patient's main clinical problem: the patient has another serious life-threatening illness likely to lead to death within the next few months
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