Point-of-care Ultrasound of Optic Nerve Sheath Diameter in Suspected Hypertensive Emergency
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 375
- 主要终点
- Papilledema
研究概览
简要总结
This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18 years old
- •Any patient presenting to the emergency department (ED) with suspected hypertensive emergency i.e.: blood pressure of > 200 millimetres of mercury (mmHg) systolic and/or > 120 mmHg diastolic
排除标准
- •Patients with preexisting optic nerve head changes such as glaucoma, pre-existing retinal artery/vein occlusions or any other condition that makes assessment of the fundi impossible.
- •Primary neurological cause of hypertension: ischemic cerebrovascular incident
结局指标
主要结局
Papilledema
时间窗: 2 years
Sensitivity of ONSD \> 5mm for diagnosis of papilledema
次要结局
- Hypertensive encephalopathy(2 years)
- Hypertensive retinopathy grade 3 & 4 combined(2 years)
- Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve(2 years)
- Rapid acting medications administered intravenously to lower the elevated blood pressure(2 years)
研究者
Tessa Mulder
Principal Investigator
Leiden University Medical Center