Individual Blood Pressure Optimization Based on Cerebral Blood Flow Autoregulation After Implantation of Continuous-flow Left Ventricular Assist Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart-Assist Devices
- Sponsor
- Baylor College of Medicine
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Individual optimal blood pressure change between before and after continuous-flow LVAD implantation determined by cerebral autoregulation monitoring with NIRS
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Kenneth Liao
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients \< 18 years of age will be ineligible for this study.
Outcomes
Primary Outcomes
Individual optimal blood pressure change between before and after continuous-flow LVAD implantation determined by cerebral autoregulation monitoring with NIRS
Time Frame: 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.
Secondary Outcomes
- 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))