Application of Healthcare Failure Mode and Effect Analysis in Nursing Risk Management of Emergency Surgery for Patients With Spontaneous Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- perioperative nursing adverse event
研究概览
简要总结
The investigators are testing whether a new nurse-led safety program (HFMEA) lowers problems during emergency brain-aneurysm surgery better than usual care.
Adults with a sudden brain bleed (subarachnoid hemorrhage) who need urgent clipping or coil placement at the hospital are randomly placed in one of two groups:
Usual nursing care, or Usual care plus HFMEA (nurses use checklists to spot and prevent risks such as re-bleeding, high brain pressure, infection, seizures).
The investigators count how often any nursing-related problems happen within 30 days after surgery, how long patients stay, and how satisfied the participants and their families are.
Results will show if this extra safety program should become standard practice.
详细描述
A single-center randomized trial of adults patients undergoing emergency repair for ruptured brain aneurysms was trying to determing that if proactive "Healthcare Failure Mode and Effect Analysis" (HFMEA) could lower the rate of nursing-related adverse events from 1 in 5 patients to fewer than 1 in 15.
Nurses trained in HFMEA mapped every step of care-from arrival through discharge-identified the 12 highest-risk moments (e.g., delayed pressure checks, missed re-bleeding signs), and built checklists, alert thresholds, and team huddles to stop problems before they started.
aim: adding a structured, forward-looking safety drill to routine neuro-critical nursing appears to spare two out of every three avoidable complications after emergency "brain-aneurysm" surgery without extra technology or cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sSAH confirmed by head CT and/or CT angiography (CTA) or digital subtraction angiography (DSA), with identified intracranial aneurysm;
- •Age 18-75 years;
- •Time from onset to admission ≤72 hours;
- •Undergoing emergency surgical treatment (open aneurysm clipping or endovascular coiling);
- •Hunt-Hess grade I-V;
- •Patient or family consent to participate in the study with signed informed consent.
排除标准
- •Traumatic subarachnoid hemorrhage;
- •Concurrent other intracranial diseases (e.g., brain tumors, arteriovenous malformations);
- •Severe cardiac, hepatic, or renal dysfunction;
- •Coagulation disorders;
- •History of psychiatric disorders or cognitive impairment;
- •Pregnancy or lactation;
- •Transfer to another hospital or treatment withdrawal.
结局指标
主要结局
perioperative nursing adverse event
时间窗: 30 days
Incidence of perioperative nursing adverse events, including: * Rebleeding * Cerebral vasospasm * Increased intracranial pressure * Seizures * Pulmonary infection * Pressure ulcers * Deep vein thrombosis * Catheter-related infections * Falls/bed exits * Medication errors, etc.
次要结局
- Nursing Quality Score(30 days)
- Family Satisfaction Degree(30 days)
- Patient Satisfaction Score(30 days)
- Length of Hospital Stay(30 days)
- 30-day Mortality(30 days)
研究者
Zhigang Lan
Professor
West China Hospital