跳至主要内容
临床试验/NCT02179840
NCT02179840撤回不适用

Assessment of Coherent Hemodynamics Spectroscopy (CHS) as a New Tool for Monitoring Cerebral Blood Flow and Autoregulation at the Microvascular Level

University of California, San Francisco2 个研究点 分布在 1 个国家开始时间: 2015年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
cerebral oximetry

研究概览

简要总结

One of the fundamental goals of anesthesia care is to optimize tissue perfusion and oxygenation, especially in critically ill patients. The standard monitors such as blood pressure, heart rate and pulse oximetry do not directly reflect tissue information and can be misleading sometimes. Coherent hemodynamics spectroscopy (CHS) based on cerebral oximetry is proposed as a continuous and non-invasive tool assessing cerebral microvascular hemodynamics. The investigators propose this study to explore the validity of CHS via comparison with transcranial Doppler measurement in anesthetized surgical patients. The hypotheses are: 1) CHS can effectively measure cerebral microvascular hemodynamic changes associated with mechanical ventilation adjustment during anesthesia. 2) CHS can assess functional status of cerebral autoregulation that is altered by hypercapnia and inhalational anesthetic agent.

详细描述

One of the essential goals in taking care of anesthetized surgical patients is to maintain adequate tissue perfusion and oxygenation. This is especially true for vital organs like the brain. Unfortunately, neither cerebral oxygen consumption nor cerebral oxygen delivery are directly monitored in the clinical setting while this type of information is of particular importance when taking care of patients inflicted with critical neurologic conditions. In addition, cerebral autoregulation - the mechanism of maintaining a constant cerebral blood flow in the face of arterial blood pressure fluctuation, is also not routinely monitored. The recent establishment of Coherent Hemodynamics Spectroscopy (CHS) is promising in offering what is needed in this context. The uniqueness of CHS is that it does not add any additional monitoring modality other than the cerebral oximeter based on near-infrared spectroscopy (NIRS) that is currently used in clinical care. However, CHS is based on its own innovative algorithm that quantifies microvascular cerebral blood flow and oxygen consumption, separates arterial and venous blood, and assesses functional status of cerebral autoregulation while the conventional cerebral oximeters do not. The investigators have established collaborations with Dr. Fantini from Tufts University and Dr. Tromberg from Beckman Laser Institute who are both leading scientists in Biophotonics research and development. Based on the clinical strength at UCSF, it is the investigators collaborative plan to explore the clinical application of CHS in patients with and without intracranial pathophysiologies. The study protocol has been submitted for review at UCSF.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

入选标准

  • Patients are 18 years of age or older
  • Relative healthy (ASA I-II)
  • Scheduled for elective intra-abdominal surgeries including colorectal, urological and gynecological procedures under general anesthesia with placements of endotracheal tube and radial arterial catheter.
  • Paralysis is required for surgery
  • A total of 30 patients will be recruited. These 30 patients are randomly divided into 2 groups based on the technique of anesthesia maintenance during surgery. The anesthesia in one group (n=15) is maintained using inhalational agent. The anesthesia in the other group (n=15) is maintained using intravenous agents.

排除标准

  • Patients <18 years of age
  • ASA physical status ≥III
  • Emergent or urgent surgery
  • Laparoscopic surgery
  • History of pulmonary diseases including COPD
  • Restrictive lung disease, etc.
  • History of cardiac diseases including symptomatic coronary artery disease, heart failure, arrhythmia, moderate to severe valvular abnormalities, and cardiomyopathies
  • History of neurological diseases including carotid artery disease, stroke or TIA, etc.

研究组 & 干预措施

Intravenous

Active Comparator

Anesthesia is maintained via intravenous agents. Mechanical ventilation adjustment will be performed.

干预措施: Mechanical ventilation adjustment (Procedure)

Inhalational

Active Comparator

Anesthesia is maintained via inhalational agents. Mechanical ventilation adjustment will be performed.

干预措施: Mechanical ventilation adjustment (Procedure)

结局指标

主要结局

cerebral oximetry

时间窗: 3 minutes following the intervention

Cerebral blood flow capillary transit time and cerebral autoregulation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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