Combined Transcranial Doppler and Optic Nerve Sheath Diameter for Early Risk Stratification of Patients With Traumatic Brain Injury in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Early Neurological Deterioration (END) within 24 hours
研究概览
简要总结
This observational study aims to evaluate the combined use of transcranial Doppler (TCD) and optic nerve sheath diameter (ONSD) ultrasound for early risk stratification of adults with traumatic brain injury (TBI) presenting to the Emergency Department. The study will assess whether ONSD measurements and TCD-derived middle cerebral artery pulsatility index (MCA-PI), in addition to clinical and computed tomography findings, can help identify patients at increased risk of early neurological deterioration. Adult patients with acute TBI and a Glasgow Coma Scale (GCS) score of 13 or less will be enrolled. TCD and ONSD measurements will be performed at emergency department presentation, with repeat measurements at 24 hours when clinically feasible in patients who have not developed early neurological deterioration. The primary outcome is early neurological deterioration within 24 hours.
详细描述
Traumatic brain injury (TBI) is a major cause of morbidity and mortality and may be complicated by secondary neurological deterioration after the initial injury. Early identification of patients at increased risk of deterioration may facilitate closer monitoring and timely escalation of neurological management.
This prospective observational cohort study will be conducted in the Emergency Department of Assiut University Hospitals. Adult patients aged 18 years or older presenting with acute traumatic brain injury, a baseline Glasgow Coma Scale (GCS) score of 13 or less, and an initial computed tomography (CT) scan demonstrating a traumatic intracranial structural lesion will be considered for inclusion. Patients with an immediate neurosurgical indication, significant orbital trauma or ocular pathology interfering with reliable ONSD measurement, previous decompressive craniectomy, or an inadequate temporal acoustic window preventing reliable MCA-TCD assessment will be excluded.
At baseline, demographic and clinical data, neurological examination findings, GCS, pupillary findings, and CT findings will be recorded. CT severity will be assessed using the Rotterdam CT score. Bilateral optic nerve sheath diameter (ONSD) measurements and transcranial Doppler (TCD) assessment of the middle cerebral arteries will be performed at baseline. MCA pulsatility index (PI) will be the prespecified primary TCD variable for the primary predictive analysis, while other TCD parameters will be recorded as secondary or exploratory variables.
Patients will be followed for 24 hours for the primary outcome of early neurological deterioration (END), defined as a new or worsening neurological abnormality attributable to TBI, including a decrease in GCS of 2 or more points from baseline when clinically assessable, a new pupillary abnormality, or a new focal neurological deficit not present at baseline.
A repeat ONSD and TCD assessment will be performed at 24 hours only in patients who have not developed END before the scheduled assessment and when clinically feasible and safe. If END occurs before 24 hours, the exact time and type of deterioration will be recorded and research ultrasound examinations will be discontinued for that patient. No event-triggered research ultrasound examination will be performed.
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
- •Adults aged 18 years or older.
- •Acute traumatic brain injury diagnosed clinically and/or radiologically.
- •Initial Glasgow Coma Scale (GCS) score ≤
- •Initial CT brain scan demonstrating a traumatic intracranial structural lesion.
- •No indication for immediate neurosurgical intervention at initial assessment.
- •Initially managed conservatively/non-operatively according to the treating team.
- •Informed consent obtained from the patient or legally authorized representative.
排除标准
- •Immediate neurosurgical indication requiring urgent intervention.
- •Immediate life-saving procedure or clinical instability preventing safe completion of the research ultrasound assessment.
- •Significant orbital trauma or ocular pathology interfering with reliable optic nerve sheath diameter measurement.
- •Previous decompressive craniectomy.
- •Inadequate temporal acoustic window preventing reliable middle cerebral artery transcranial Doppler assessment.
- •Refusal to participate or withdrawal of consent.
研究组 & 干预措施
Patients with Traumatic Brain Injury
Adult patients presenting to the Emergency Department with acute traumatic brain injury who meet the predefined eligibility criteria and undergo baseline transcranial Doppler and optic nerve sheath diameter assessment for early risk stratification and subsequent assessment of neurological outcomes.
干预措施: Transcranial Doppler and Optic Nerve Sheath Diameter Assessment (Diagnostic Test)
结局指标
主要结局
Early Neurological Deterioration (END) within 24 hours
时间窗: Within 24 hours of Emergency Department presentation
Early neurological deterioration (END) will be defined as a new or worsening neurological abnormality attributable to traumatic brain injury, including: (1) a decrease in Glasgow Coma Scale (GCS) score of 2 or more points from baseline when clinically assessable; (2) a new pupillary abnormality; or (3) a new focal neurological deficit not present at baseline. END is recorded independently of subsequent escalation of care or neurosurgical intervention.
次要结局
- Radiological progression of traumatic brain injury(Within 24 hours after Emergency Department presentation.)
- Escalation of neurological management(Within 24 hours after Emergency Department presentation)
- In-hospital mortality(From Emergency Department presentation until hospital discharge or death, whichever occurs first.)
研究者
Doaa Ahmed Mohamed
Principal investigator
Assiut University