Utility of Optic Nerve Ultrasonography in Assessing Cerebral Inflammation and Intracranial Hypertension in Patients With Cerebral Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Optic Nerve Sheath Diameter
研究概览
简要总结
Timely detection of signs of raised intracranial pressure or persistent inflammation within the meninges can expedite therapeutic decisions improving the prognosis of patients with brain damage. Optic nerve ultrasonography provides a user-friendly, safe, low-cost, and non-invasive imaging method that can be easily deployed for ICU patient assessment. This study aims to evaluate the sensitivity and specificity of optic nerve ultrasound in estimating cerebral inflammation extension and cerebral edema in patients in the ICU. The working hypothesis is that optic nerve ultrasound is a useful tool in the rapid diagnosis of cerebral edema and the presence or persistence of cerebral inflammation, which can enable adapted and rapid therapeutic interventions.
详细描述
"Utility of Optic Nerve Ultrasonography in Assessing Cerebral Inflammation and Intracranial Hypertension in Patients with Cerebral Impairment" - briefly, the EICON Study.
Investigators Principal Investigator (1): Bogdan PAVEL, MD, PhD, DESA, "Dr. Victor Babes" Clinical Hospital of Infectious and Tropical Diseases.
Principal Investigator (2): Sebastian ISAC, MD, PhD, DESA, Fundeni Clinical Institute Principal Investigator (3): Prof. Gabriela DROC, M.D., Ph.D., Fundeni Clinical Institute
Study Design Study Type: Observational Estimated Number of Participants: 200 participants Primary Purpose: Evaluation Actual Study Start Date: December 1st, 2025 Estimated Primary Completion Date: December 1st, 2027 Estimated Study Completion Date: December 1st, 2027
Groups and Interventions
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted into one of the specified wards of the involved hospitals
- •Patients aged 18-60 years
- •Suspected meningitis, encephalitis, stroke or cerebral tumors
排除标准
- •Age under 18 years or over 60 years old
- •Ocular lesions preventing ocular ultrasound (palpebral infections, cornean erosions, glaucoma, trauma)
- •Conditions preventing lumbar puncture (coagulation disorders, epidural abscesses, local infections)
研究组 & 干预措施
Infectious Pathology Group
Patients admitted into the hospital with suspected meningitis or encephalitis
干预措施: Optic Nerve Sheath Diameter (Diagnostic Test)
Non-Infectious Pathology Group
Patients admitted into the hospital with suspected stroke or cerebral tumors (non-infectious pathology)
干预措施: Optic Nerve Sheath Diameter (Diagnostic Test)
结局指标
主要结局
Optic Nerve Sheath Diameter
时间窗: Daily during the first week of hospitalisation
The diameter of the optic nerve sheath measured ultrasonographically using a standardised method, 6mm from the surface of the retina
次要结局
- Richmond Agitation-Sedation Scale(Daily during the first week of hospitalisation)
- Middle Cerebral Artery Pulsatility Index(Daily during the first week of hospitalisation)
- Glasgow Coma Scale(Daily during the first week of hospitalisation)
- Neuron-specific Enolase(Day 1, day 3 and day 7)
- CSF examination(Day 1, day 3 and day 7)
- C-reactive protein(Day 1, day 3 and day 7)
研究者
Bogdan Pavel
MD, PhD, DESA
Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"