Vascular Endovascular Therapy: A Nurse-Led Predictive Nursing Protocol for Neurological Complications-Development, Validation, and Clinical Impact
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- AUC of the checklist
研究概览
简要总结
The goal of this prospective cohort study was to develop and test a 12-item, nurse-led predictive checklist that can quickly identify patients at high risk for neurological complications (bleeding, re-blockage, brain swelling, etc.) after endovascular therapy (EVT) for stroke or unruptured aneurysms. The main questions it aims to answer are:
Does the checklist accurately flag complications (sensitivity/specificity)? Does its use shorten the time between first abnormal sign and physician action? Does it lower the rate of severe complications or death and shorten hospital stay? Researchers compared 213 patients managed with the checklist (intervention group) to 213 patients who received standard nursing observation (control group).
Participants were:
Assessed by nurses at 6, 12, 24, and 48 hours post-EVT with the checklist (intervention) or usual monitoring (control) Followed for 7 days for any neurological complication and for 30 days for severe outcomes Checked with urgent CT/MRI and treated whenever the checklist score indicated high risk (≥4/12 points)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old, underwent EVT for AIS (due to anterior circulation large vessel occlusion) or UIAs (size ≥5 mm)
- •had a postoperative stay of ≥48 hours.
排除标准
- •preprocedural intracranial hemorrhage;
- •severe liver or kidney dysfunction;
- •coagulation disorders;
- •refusal to participate in the study.
结局指标
主要结局
AUC of the checklist
时间窗: 7 days
AUC of the checklist for predicting any neurological complication (HT, reocclusion, MCE, sICH) within 7 days postprocedural. Complications were diagnosed by neurointerventional physicians based on clinical manifestations and imaging findings (CT/MRI).
次要结局
- incidence of severe complications(30 days)
- length of hospital stay(30 days)
- 30-day mortality(30 days)
研究者
Zhigang Lan
Professor
West China Hospital