CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State - CERBERUS Trial

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The goal of this observational study is to learn the how to determine the mean arterial pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for optimal brain health in patients above the age of 60 undergoing major non-cardiac surgery. The main question\[s\] it aims to answer are: * Is there a way to tailor the blood pressure to be maintained in such patients during surgery for optimal brain health using non-invasive monitors that check the brains electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood oxygen levels, the cerebral oximetry(CO) monitor? * How much does this optimal blood pressure level vary between patients? Participants will be asked to: * Complete a questionnaire at the time they enroll into the study, as well as a daily questionnaire to help determine their level of thinking and brain health. This questionnaire will be administered by a member of the study team. * They will also have an EEG and CO monitoring sticker placed on their foreheads. This will be connected to a monitor that will collect this data just before, during, and after their surgery. The data collected through these monitors will help us with our study goals.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• Age ≥ 60 years

• Undergoing any non-cardiac surgeries including but not limited to vascular, hepatobiliary, or complex spine surgeries requiring general anesthesia with arterial catheterization for monitoring

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Samir M Kendale, MD
skendale@bidmc.harvard.edu
(617) 975-8500
Backup
Zaid Hussain, MBBS
zhussai1@bidmc.harvard.edu
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2025-09
Participants
Target number of participants: 100
Treatments
Enrolled Participants
Patients above the age of 60 undergoing major non-cardiac surgery requiring invasive MAP monitoring as standard of care. They will be monitored intra-op using non-invasive EEG and CO monitors, which will be correlated with MAP.~They will also undergo baseline and followup assessment for post-operative delirium using the standardised CAM and MoCA tools administered by study staff.
Related Therapeutic Areas
Sponsors
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov