Individual Blood Pressure Optimization Based on Cerebral Autoregulation After Implantation of Continuous-flow LVAD (NIRS)

Baylor College of Medicine

Status: Completed

Conditions: Heart Failure; Heart-Assist Devices

Study type: Observational

Funder types: Other

Identifiers

NCT03093012

H-34866

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.