Continuous determination of optimal cerebral perfusion pressure in traumatic brain injury.
Marcel J H Aries, Marek Czosnyka, Karol P Budohoski...
https://pubmed.ncbi.nlm.nih.gov/22622398Actively Recruiting
Age: 60Years +
All Genders
Healthy Volunteers
ID06133842
CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State - CERBERUS Trial
Led by Beth Israel Deaconess Medical Center · Updated on 2025-10-28
100
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients over 60 years old undergoing major non-cardiac surgery to find the best blood pressure level to maintain during surgery for optimal brain health. This observational study aims to determine if non-invasive monitors measuring brain electrical activity (EEG) and blood oxygen levels (cerebral oximetry) can help tailor blood pressure for each individual and understand how much this optimal level differs between patients. Participants will have EEG and cerebral oximetry monitoring stickers placed on their foreheads before surgery, which will collect data throughout the surgery and up to 24 hours afterward or until extubation. These monitors will be connected to specialized equipment that records brain and blood pressure data in real-time without affecting medical care. The study includes assessments before surgery, during surgery, and after surgery, including cognitive and delirium testing using standardized tools like the Montreal Cognitive Assessment (MoCA) and Confusion Assessment Method (CAM). During the study, participants will complete questionnaires about their brain health at enrollment and daily after surgery. They will undergo baseline cognitive testing before surgery, continuous brain monitoring during surgery, and daily cognitive and delirium assessments during hospitalization. Follow-up assessments by phone will occur at one month and six months after surgery. Researchers will also collect medical data such as medications, pain scores, and vital signs to analyze alongside cognitive outcomes. The primary focus is on measuring cerebral autoregulation and brain function related to blood pressure during and after surgery.
CONDITIONS
Brief Title
CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State
Who Can Participate
Age: 60Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Undergoing major non-cardiac surgery requiring general anesthesia and arterial catheter monitoring
- Able to understand and speak English
You will not qualify if you...
- Non-English speaking
- Cognitive impairment with MoCA score less than 10
- Significant visual impairment
- Emergency surgery
- History of stroke within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Duration of surgery and up to 24 hours post-surgery or until extubation or transfer from PACU, whichever occurs first
Participants undergo intraoperative non-invasive EEG and cerebral oximetry (CO) monitoring alongside standard arterial catheter monitoring to assess cerebral autoregulation during surgery.
1 continuous monitoring session during surgery and immediate postoperative period
Monitoring
Duration - Up to 1 week or until hospital discharge
Participants have daily cognitive, delirium, and pain assessments during their hospital stay, including standardized tests and medical chart reviews to identify postoperative delirium and related events.
Daily visits during hospital stay; frequency may reduce after 3 consecutive delirium-negative days
Long-term Monitoring
Duration - Up to 6 months post-surgery
Participants complete follow-up assessments via telephone at 1 month and 6 months after surgery to evaluate cognitive function, delirium symptoms, pain, and functional status.
2 phone call assessments (at 1 month and 6 months post-surgery)
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
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Research Team
S
Samir M Kendale, MD
Z
Zaid Hussain, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Continuous Near-infrared Spectroscopy Monitoring in Adult Traumatic Brain Injury: A Systematic Review.
François Mathieu, Abdelhakim Khellaf, Jerry C Ku...
https://pubmed.ncbi.nlm.nih.gov/31306264Arterial pressure above the upper cerebral autoregulation limit during cardiopulmonary bypass is associated with postoperative delirium.
D Hori, C Brown, M Ono...
https://pubmed.ncbi.nlm.nih.gov/25256545Early Versus Delayed Stroke After Cardiac Surgery: A Systematic Review and Meta-Analysis.
Mario Gaudino, Mohammed Rahouma, Michele Di Mauro...
https://pubmed.ncbi.nlm.nih.gov/31215306Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery.
Louise Y Sun, Amy M Chung, Michael E Farkouh...
https://pubmed.ncbi.nlm.nih.gov/29889106Association Between Intraoperative Arterial Hypotension and Postoperative Delirium After Noncardiac Surgery: A Retrospective Multicenter Cohort Study.
Luca J Wachtendorf, Omid Azimaraghi, Peter Santer...
https://pubmed.ncbi.nlm.nih.gov/34517389Association Between Perioperative Hypotension and Delirium in Postoperative Critically Ill Patients: A Retrospective Cohort Analysis.
Kamal Maheshwari, Sanchit Ahuja, Ashish K Khanna...
https://pubmed.ncbi.nlm.nih.gov/31725024Postoperative delirium.
E L Whitlock, A Vannucci, M S Avidan
https://pubmed.ncbi.nlm.nih.gov/21483389Cognitive trajectories after postoperative delirium.
Jane S Saczynski, Edward R Marcantonio, Lien Quach...
https://pubmed.ncbi.nlm.nih.gov/22762316Determining Thresholds for Three Indices of Autoregulation to Identify the Lower Limit of Autoregulation During Cardiac Surgery.
Xiuyun Liu, Kei Akiyoshi, Mitsunori Nakano...
https://pubmed.ncbi.nlm.nih.gov/33278074