Whole-process Quality Improvement of Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment Based on an Artificial Intelligence-aided Clinical Feedback System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,289
- 试验地点
- 1
- 主要终点
- Ratio of favorable functional outcome at 3 month
研究概览
简要总结
A clustered randomized control trial to evaluate whether multi-aspect intervention based on an AI-aided clinical feedback system could improve the quality of EVT and functional outcome of patients.
详细描述
Endovascular treatment (EVT) is the standard treatment for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) according to current guidelines. However, while a rapidly-growing number of stroke centers become capable of performing EVT, the general quality of EVT remains unsatisfied, resulting in a considerable proportion of patients who could not reach functional independence. Our pre-established artificial intelligence (AI)-aided clinical feedback system could dynamically record and report key timepoints of EVT in-hospital process. Combined with multi-aspect intervention via remote/on-site surveillance and education, this may be a potential solution for quality improvement of EVT. Therefore, the aim of the study is to evaluate whether an AI-aided clinical feedback system coupled with multi-aspect intervention could improve the quality of EVT. Twenty hospitals with annual EVT cases > 30 will be 1:1 randomized into intervention group and control group. The intervention group will receive AI-based clinical feedback system coupled with multi-aspect intervention, including remote/on-site surveillance and education regarding in-hospital workflow and surgical procedures of EVT. The control group only deploys AI-aided clinical feedback system. The primary outcome is the ratio of good functional outcome at 3 month.
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
- Double (Participant, Outcomes Assessor)
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
- •AIS patients receiving EVT within 24 hours of stroke onset
- •Written informed consent is obtained
排除标准
- •Patients refuse to participate in this study
结局指标
主要结局
Ratio of favorable functional outcome at 3 month
时间窗: 3 months
Ratio of patients with mRS ≤ 3 at 3-month follow up
Ratio of favorable functional outcome at 3 month
时间窗: 3 months
Ratio of patients with mRS ≤ 3 at 3-month follow up
次要结局
- Door to groin puncture time(24 hours)
- Ratio of door to groin puncture time < 90 min(24 hours)
- Ratio of door to groin puncture time < 60 min(24 hours)
- Procedural duration(24 hours)
- Ratio of successful reperfusion(24 hours)
- Ratio of good functional outcome at 3 month(3 months)
- mRS score at 3 month(3 months)
- Mortality at 3 month(3 months)
- Ratio of hemorrhagic transformation at 24 hour(24 hours)
- Ratio of symptomatic intracranial hemorrhage at 24 hour(24 hours)
- Ratio of good functional outcome at 3 month(3 months)
- mRS score at 3 month(3 months)
- Door to groin puncture time(24 hours)
- Mortality at 3 month(3 months)
- Ratio of hemorrhagic transformation at 24 hour(24 hours)
- Ratio of symptomatic intracranial hemorrhage at 24 hour(24 hours)
- Ratio of door to groin puncture time < 90 min(24 hours)
- Ratio of successful reperfusion(24 hours)
- Ratio of door to groin puncture time < 60 min(24 hours)
- Procedural duration(24 hours)