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临床试验/NCT06932640
NCT06932640尚未招募不适用

Continuous Assessment of Cerebral Autoregulation in Subarachnoid Hemorrhage (SAH) Patients Using Cerebral Oximetry Index and Hemoglobin Volume Reactivity Index

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Change in Lower Limit of Autoregulation (LLA)

研究概览

简要总结

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 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: - Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor) (Device)

结局指标

主要结局

Change in Lower Limit of Autoregulation (LLA)

时间窗: 21 days

Successful calculations of moving Lower Limit of Autoregulation (LLA) for all three algorithms

次要结局

  • Change of delayed cerebral ischemia (DCI) to the average LLA(21 days)
  • Change in time under LLA(21 days)
  • Change in dose under LLA(21 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Weifeng Song

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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