Is The Ratio of Optic Nerve Sheath Diameter to Eyeball Transverse Diameter Correlated With The Prognosis of Sepsis Associated Encephalopathy in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 主要终点
- Correlation between US ratio of ONSD/ETD and neurologic outcome 3 months following ICU discharge in critically ill patients with SAE.
研究概览
简要总结
Sepsis is associated with a mortality rate of 20-25%, with significant increase in case of associated comorbidities or shock. SAE is one of the most common forms of encephalopathy encountered in critically ill patients, with increased ICP as a possible underlying mechanism. Many studies revealed that ONSD is a valuable ICP monitoring tool. Also, ONSD/ETD ratio, according to previous studies, seemed to be more reliable than ONSD alone in predicting neurological outcomes of comatosed patients. The present study will assess the correlation between US-ONSD/ETD ratio and the prognosis of SAE in critically ill patients.
详细描述
Site of the Study: Surgical intensive care units, Zagazig University Hospitals.
Duration of Study: Around 6 months. Type of the Study: Prospective observational study.
Sample Size:
Sample size is calculated to be 89 patients assuming that the area under curve (AUC) of the ONSD/ETD ratio in predicting prognosis of comatose patients was 0.808 (95%CI: 0.696 - 0.920) with confidence level 0.95.
Withdrawal Criteria:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acceptance of one of patient's 1st degree relatives.
- •Age ≥ 18 and ≤ 65 years old of both sexes.
- •Sedated or unconscious patients and on invasive mechanical ventilation.
- •Patients diagnosed with sepsis associated encephalopathy (SAE);
排除标准
- •Ocular and/or optic nerve pathology; e.g., ocular trauma or surgery, previous ocular pathology as glaucoma or cataract, conjunctival or orbital edema, vitreous hemorrhage and optic nerve disease or injury.
- •Intracranial pathology; e.g., central nervous system (CNS) infection, cerebrovascular accident, cerebral hemorrhage, brain trauma or tumor, and any previous neurosurgical procedure.
- •Toxic or metabolic encephalopathy, e.g., alcohol toxicity, liver or kidney disease.
- •Serious co-morbidities that could affect life expectancy, e.g., hematopathy or cancer.
结局指标
主要结局
Correlation between US ratio of ONSD/ETD and neurologic outcome 3 months following ICU discharge in critically ill patients with SAE.
时间窗: 3 months following ICU discharge
Correlation between US ratio of ONSD/ETD and neurologic outcome 3 months following ICU discharge in critically ill patients with SAE.
次要结局
- Correlation between US ratio of ONSD/ETD and ICU-LOS in critically ill patients with SAE.(From date of enrolling in the study until the date of discharge from ICU or date of death from any cause, whichever came first, assessed up to 90-days)
- Correlation between US ratio of ONSD/ETD and neurologic outcome on ICU discharge in critically ill patients with SAE.(From date of enrolling in the study until the date of discharge from ICU or date of death from any cause, whichever came first, assessed up to 90-days)
- Correlation between US ratio of ONSD/ETD and 90-day mortality in critically ill patients with SAE.(90-days)
研究者
Ashraf Torki
Lecturer of Anesthesia, Zagazig University (Principal Investigator)
Zagazig University