使用近红外光谱（NIRS）连续评估蛛网膜下腔出血患者的脑血液灌注
连续评估使用脑血氧馆指数和血红蛋白体积反应性指数的蛛网膜下腔出血（SAH）患者的脑自动调节
The goal of this observational study is to continuously assess cerebral autoregulation in patients with subarachnoid hemorrhage (SAH) using cerebral oximetry index (COx) and hemoglobin volume reactivity index (HVx). The main question it aims to answer is: Whether optimal perfusion pressure is dynamic and changes with time in patients with SAH, and that autoregulation is disrupted in patients during the course of SAH, contributing to delayed cerebral ischemia (DCI).
研究概览
地位
条件
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：LaShun L. Horn, M.S.
- 电话号码：205-996-2606
- 邮箱：llhorn@uabmc.edu
研究联系人备份
- 姓名：Roxana Santander-Chapeta
- 电话号码：205-975-2846
- 邮箱：rsantanderchapeta@uabmc.edu
学习地点
-
-
Alabama
-
Birmingham、Alabama、美国、35294
- The University of Alabama at Birmingham
-
接触：
- Weifeng Song, M.D., Ph.D
- 电话号码：205-934-4699
- 邮箱：wsong@uabmc.edu
-
首席研究员：
- Weifeng Song, M.D., Ph.D
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Neurological Intensive Care Unit (NICU) patients
描述
Inclusion Criteria:
- Patients aged 18 to 89 years who are admitted to the Neurological Intensive Care Unit (Neuro ICU) between March 2025 and December 2026 for aneurysmal subarachnoid hemorrhage (SAH).
Exclusion Criteria:
- Patients under 18 years old
- Prisoners
- Pregnant women
- Patients enrolled in concurrent ongoing interventional trial
- Students of UAB
- Employees of UAB
- Patients who undergoes frontal decompression surgery resulting bone flap deficit where NIRS monitoring pads could not be applied.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Aneurysmal subarachnoid hemorrhage (SAH) patients
The study will be conducted on patients aged 18 to 89 years admitted to the Neurological Intensive Care Unit (ICU) with a Aneurysmal subarachnoid hemorrhage (SAH). The study will use near-infrared spectroscopy (NIRS) monitors (which is outside standard of care) and transcranial doppler (TCD, only when available and is standard of care) that will be attached to these patients. The data from these devices will be used solely for analysis after the patients have been discharged. |
Near-Infrared Spectroscopy (NIRS) monitors, provided by Edwards Lifesciences, is a monitoring technique. It will be connected to consented patients, automatically capturing brain oxygen as waveform output, and stored in Sickbay system. The NIRS is a non-invasive monitoring method, in which adhesive pads will be applied to forehead. 4 hours continuous monitoring will be recorded on day 1 after SAH (or on presence to NICU), then every three days from day 3 to day 14 (within the DCI window), to 1 to 2 recordings from day 15 to day 21. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Lower Limit of Autoregulation (LLA)
大体时间：21 days
|
Successful calculations of moving Lower Limit of Autoregulation (LLA) for all three algorithms |
21 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change of delayed cerebral ischemia (DCI) to the average LLA
大体时间：21 days
|
Correlation of clinical course of delayed cerebral ischemia (DCI) to average LLA |
21 days
|
|
Change in time under LLA
大体时间：21 days
|
Correlation in time under LLA |
21 days
|
|
Change in dose under LLA
大体时间：21 days
|
Correlation in dose under LLA |
21 days
|
合作者和调查者
调查人员
- 首席研究员：Weifeng Song, M.D., Ph.D、The University of Alabama at Birmingham
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB-300014488
- HCP-135292794 (其他赠款/资助编号：Edwards Lifesciences Corp.)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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