AutOmated Pupillometry and OpTic nerve sheath dIameter for prediCtion of neurological outcome in patients with aneurysmal Subarachnoid hemorrhage– the OPTICS study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Extended Glasgow outcome scale [GOSE]) at discharge from hospital and at 3 months post aSAH
研究概览
简要总结
All participants in our study will be evaluated for various demographic parameters, such as age, gender, and comorbidities. Consciousness will be evaluated using the GCS and pupil reactivity will also be assessed. Physiological metrics (including Mean Arterial Pressure (MAP), Heart Rate (HR), Respiratory Rate (RR), and Oxygen Saturation (SpO2)), along with laboratory parameters such as blood glucose levels, serum sodium, and PaCo2 levels, will be documented.
In addition, other parameters like the timing of ictus, grades of subarachnoid hemorrhage (including Hunt and Hess grade, modified Fischer’s grade, and WFNS grade), pupillary reactivity, presence of hydrocephalus, insertion of external ventricular drain and vasospasm will be recorded.
Measurements of Optic Nerve Sheath Diameter (ONSD) will be conducted alongside. Automated Pupillometry (AP) measurements. These assessments will occur at baseline, as well as at 24 hours, 48 hours, and on 72 hours following admission, with trends being carefully documented. The patient’s outcome will be assessed by extended Glasgow outcome scale (GOSE) at discharge from the hospital and telephonically 3 months after the ictus.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Adult patients (more than 18 years) with a confirmed diagnosis of aSAH b) less than 5 days of ictus c) Able to undergo non-invasive testing ONSD measurement and AP.
排除标准
- •a) Pre-existing eye diseases or optic nerve pathology (e.g., optic neuritis, glaucoma).
- •b) more than 5 days of ictus c) Requirement for immediate surgery or interventions that prevent non-invasive testing.
- •d) Pregnancy.
- •e) Significant comorbidities, such as terminal cancer, that would complicate the study’s outcome measures.
结局指标
主要结局
Extended Glasgow outcome scale [GOSE]) at discharge from hospital and at 3 months post aSAH
时间窗: Extended Glasgow outcome scale [GOSE]) at discharge from hospital and at 3 months post aSAH
次要结局
- 1. Mortality within 30 days of aSAH.
研究者
DR RICHA PARIHAR
ALL INDIA INSTITUE OF MEDICAL SCIENCES NEW DELHI