Sedation vs. Intubation for Endovascular Stroke TreAtment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- National Institutes of Health Stroke Scale (NIHSS) after 24 hours
研究概览
简要总结
Sedation vs Intubation for Endovascular Stroke TreAtment Trial (SIESTA) is a prospective, randomised controlled, monocentric, two-armed, comparative trial. Patients are randomized 1 : 1 to either non-intubated state or to intubated state for endovascular stroke treatment. Otherwise, no principal differences in intensive care treatment are intended, and standard operating procedures are applied to ensure uniform management decisions in fields such as ventilation, sedation, cardio-vascular and cerebral monitoring and management.
详细描述
Early recanalization is an important, if not the most important, factor concerning reconstitution of patients´ health in ischaemic stroke. This is the reason why patients with extended stroke are increasingly subjected to an endovascular stroke therapy (EST).
Matter of ongoing debate is how to sedate these patients during intervention. Some clinicians prefer an intubation due to a reduction of patients´movements and therefore potentially lowering complication rates (injury by catheter, aspiration e.g.).
On the other hand retrospective investigations hypothesize that general anaesthesia is associated with peri-interventional hypotension followed by poorer clinical outcome.
The best anaesthaesiologic management in endovascular stroke therapy to this point of time is not known. The investigators therefore designed this study comparing intubated state with general anaesthesia vs. non-intubated state with conscious sedation during EST, focusing on patients´ outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •age ≥18 years
- •acute stroke in anterior circulation
- •occlusion of carotid artery and/ or middle cerebral artery
- •planned mechanical recanalisation
- •informed consent from patient or legal representative
排除标准
- •age < 18 years
- •informed consent not obtainable
- •agitation
- •difficult airway management
- •additional cerebral hemorrhage
结局指标
主要结局
National Institutes of Health Stroke Scale (NIHSS) after 24 hours
时间窗: 24 hours
Neurological improvement of NIHSS 24 hours after intervention
次要结局
- Mortality-rate within the first 3 months after intervention.(First 3 months after intervention)
- Inpatient-mortality(Mortality-rate until timepoint of discharge, an expected average of 3 weeks.)
- Outcome after 3 month using the modified Rankin Scale (mRS)(3 month)
研究者
Dr. Silvia Schönenberger, MD
Leading sub-investigator, Principal Investigator: PD Dr. Julian Bösel, MD
University Hospital Heidelberg