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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06133842
Status
Recruiting
Apply to this trial

Conditions

  • Cerebral Hypoperfusion
  • EEG With Periodic Abnormalities
  • Intraoperative Hypotension
  • Perioperative/Postoperative Complications
  • Postoperative Cognitive Dysfunction
  • Postoperative Delirium

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Intra-op EEG and CO data collection — DIAGNOSTIC_TEST
    Intra-op EEG and CO data will be collected non-invasively. This will not guide or affect patient care of procedure in any way.

Study Details

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.

Key Dates

Start date
Apr 17, 2024
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

CA state and lower limits of autoregulation (LLA): [ Time Frame: 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Samir Kendale, MD
[email protected]

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MA

Related Studies