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临床试验/NCT06565442
NCT06565442尚未招募不适用

Feasibility of Using NeuraSignal Transcranial Doppler Robot for Generating Cerebral Autoregulation Curves in Neuro ICU Patients Admitted for Blood Pressure Management After Spinal Surgery

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年12月15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
20
试验地点
2
主要终点
Primary outcome

研究概览

简要总结

The purpose of this study is to determine the feasibility of using the NeuraSignal transcranial doppler robot in a neuro ICU setting to measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves

详细描述

This study aims to explore the feasibility of using the NeuraSignal transcranial doppler robot to generate cerebral autoregulation curves in adult patients admitted to the neuro ICU with a newly diagnosed brain mass. Cerebral blood flow measurements as calculated by a transcranial doppler robot will be time-correlated with arterial blood pressure measurements to generate personalized cerebral autoregulation curves. The study will be conducted prospectively and observationally on 20 patients as a pilot study for feasibility management.

Cerebral autoregulation has historically been difficult to quantify, in part due to the difficulty in measuring cerebral blood flow directly. Transcranial doppler (TCD) is a well-established method of calculating cerebral blood flow based on velocity through the middle cerebral arteries, however traditional methods of performing TCD are time consuming and require technical and procedural training. It also carries the established risk of miscalculation with variation in intra-operator technique differences and miscalculations due to inappropriate angle of the probe. The NeuraSignal transcranial doppler robot offers a potential tool to make obtaining cerebral blood flow calculations easier and, with the use of AI to determine optimal windows, significantly decreases intra-operator differences and errors associated with inappropriate probe angle. Cerebral blood flow calculated in this way can then be correlated with arterial blood pressure and used to build cerebral autoregulatory curves in near real time. This study aims to build on previous studies deriving and using personalized cerebral autoregulatory curves and determine the feasibility of using the TCD robot in this way to make individualized cerebral autoregulatory curves more accessible as a tool for personalized blood pressure management.

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

入选标准

  • Patients admitted to the Neuro ICU for blood pressure management (MAP management) after spinal surgery

排除标准

  • Patients under 18 years (or bodyweight <50kg if age unknown),
  • prisoners
  • pregnant women,
  • non-English speaking,
  • patients enrolled in concurrent
  • ongoing interventional trial
  • students of UAB
  • employees of UAB
  • targeting specific populations
  • patients with previously diagnosed brain pathology
  • patients with open wounds over temporal bones precluding transcranial doppler

研究组 & 干预措施

Study Group

Using the NeuraSignal transcranial doppler robot in a neuro ICU setting to measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves.

干预措施: NeuraSignal transcranial doppler robot (Device)

结局指标

主要结局

Primary outcome

时间窗: one year

Cerebral autoregulatory curve generation using the NeuraSignal transcranial doppler robot correlated with arterial blood pressure measurements in neuro ICU patients admitted for blood pressure management after spinal surgery

次要结局

  • Secondary outcome(one year)

研究者

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

Emily Wasson

MD, MPH Assistant Professor Division of Critical Care Department of Anesthesiology and Perioperative Medicine

University of Alabama at Birmingham

研究点 (2)

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