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临床试验/NCT03093012
NCT03093012已完成不适用

Individual Blood Pressure Optimization Based on Cerebral Blood Flow Autoregulation After Implantation of Continuous-flow Left Ventricular Assist Device

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
1
主要终点
Individual optimal blood pressure change between before and after continuous-flow LVAD implantation determined by cerebral autoregulation monitoring with NIRS

研究概览

简要总结

This study will collect retrospective and prospective clinical data regarding the Principal Investigator's patient population to allow for data analysis seeking basic trends and to prepare academic reports, including journal manuscripts and presentations for scientific organizations.

详细描述

Preoperative data will be collected as the baseline information through chart review and patient interview before the surgery as follows: patient demographics, co-morbidities, medication, preoperative laboratory results, and preoperative vital signs.

Intraoperative data will be collected by chart review or monitor review as follows: type of implant device, concomitant procedures, length of surgery, duration of cardiopulmonary bypass and aortic cross clamp, blood products administered hemodynamic variables, and NIRS signals.

Postoperative data will be collected by chart review or monitor review as follows: medications, blood products administered, postoperative laboratory results, adverse events and operative mortality*, length of mechanical ventilation, length of inotrope administered, hemodynamic variables, length of intensive care unit and hospital stay, mortality, and NIRS signals.

Participants will receive routine standard institutional perioperative care that included invasive radial artery blood pressure monitoring. Participants will be connected to the NIRS monitor using sensor probes placed on the right and left sides of the forehead per routine clinical application. NIRS signal monitoring will be initiated before induction of general anesthesia in the operation room for collecting baseline data, and continued during LVAD implantation procedure. After implantation of LVAD, continuous NIRS monitoring will be carried out in the ICU until termination of the invasive arterial blood pressure monitoring.

For all participants enrolled in this study, all medical treatment which is provided will not deviate from the standard of clinical care, including surgery and other procedures as well as blood sample collection. The data will be reviewed routinely to seek trends. When needed to examine specific clinical issues, such as risk factors for a given complication, additional clinical data will be retrieved from the medical records. All data sets analyzed and used for presentations or publication will be anonymized to protect patient confidentiality. This study will be conducted indefinitely.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients greater than or equal to 18 years old undergoing continuous-flow left ventricular assist device implantation for the clinical indications of bridge to transplant or destination therapy.

排除标准

  • Patients < 18 years of age will be ineligible for this study.

结局指标

主要结局

Individual optimal blood pressure change between before and after continuous-flow LVAD implantation determined by cerebral autoregulation monitoring with NIRS

时间窗: From initiation of cerebral autoregulation monitoring in operation room until termination of the invasive arterial blood pressure monitoring in ICU (up to 48 hours)

Using cerebral autoregulation monitoring method, the optimal blood pressure for maintaining cerebral blood flow (CBF) can be determined individually. The individual optimal blood pressure to maintain CBF autoregulation will be determined and assessing change between before and after implantation of continuous-flow LVAD.

次要结局

  • Postoperative adverse events and operative mortality after continuous-flow LVAD implantation.(From implantation of continuous-flow LVAD until discharge of hospital (up to 4 weeks))
  • Extent of impairment of cerebral autoregulation in perioperative periods(From initiation of cerebral autoregulation monitoring in operation room until termination of the invasive arterial blood pressure monitoring in ICU (up to 48 hours))

研究者

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

Kenneth Liao

Principal Investigator

Baylor College of Medicine

研究点 (1)

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