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

NCT06133842 | Recruiting FDA Device

• 1 other identifier: 2023-P-000843
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

EEG; Cerebral Autoregulation; Intraoperative Monitoring

Outcome Measures

Primary Outcomes (1)

• CA state and lower limits of autoregulation (LLA):

  The primary outcome will be reliability in the form of an "uptime". This is a calculation of the percentage that each signal provides a feasible measurement, and a percentage that each method of autoregulation calculation produces an output. Previous studies have demonstrated a high frequency of uptime, upwards of 90%. CA state and lower limits of autoregulation (LLA) will be calculated using two distinct methods, both previously published and enumerated in the Statistical Consideration section

  1 week

Secondary Outcomes (7)

• Duration of burst suppression in EEG

  1 week

• Incidence of Postoperative Delirium (POD)

  Within 1 week

• Cognitive function

  1 month and 6 months

• Hemodynamic stability - Vasopressor Usage

  1 week

• Hemodynamic stability - Time outside ideal systolic range

  1 week

Study Arms (1)

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.

Diagnostic Test: Intra-op EEG and CO data collection

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.

Also known as: Massimo SEDLINE Root Monitor

Enrolled Participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients above the age of 60 scheduled to undergo major non-cardiac surgeries including but not limited to vascular, hepatobiliary, or complex spine surgeries requiring general anesthesia with arterial catheterization for monitoring.

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking (Justification: cognitive assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)
• Cognitive impairment as defined by total MoCA score \< 10 (justification: baseline cognitive dysfunction will confound primary outcome measure)
• Significant visual impairment (justification: will be difficult for patients to draw individual components in MOCA score)
• Emergent surgery (justification: insufficient time to initiate intervention)
• History of stroke within the last 3 months (justification: cognitive dysfunction secondary to stroke can confound outcome measures

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (21)

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• Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298.

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  PMID: 22762316 BACKGROUND

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• Goettel N, Burkhart CS, Rossi A, Cabella BC, Berres M, Monsch AU, Czosnyka M, Steiner LA. Associations Between Impaired Cerebral Blood Flow Autoregulation, Cerebral Oxygenation, and Biomarkers of Brain Injury and Postoperative Cognitive Dysfunction in Elderly Patients After Major Noncardiac Surgery. Anesth Analg. 2017 Mar;124(3):934-942. doi: 10.1213/ANE.0000000000001803.

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MeSH Terms

Conditions

Postoperative Complications; Postoperative Cognitive Complications; Emergence Delirium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Central Study Contacts

Samir M Kendale, MD

CONTACT

(617) 975-8500; skendale@bidmc.harvard.edu

Zaid Hussain, MBBS

CONTACT

zhussai1@bidmc.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesia at the Harvard Medical School, Director of Neuroanesthesia at BIDMC

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 18, 2023
• Study Start: April 17, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)