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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorBeth Israel Deaconess Medical Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Enrolled Participants1 intervention

Trial outcomes

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

Time frame
1 week

Secondary outcomes

1

Duration of burst suppression in EEG

Determine the length of burst suppression on EEG monitoring for each patient. Burst suppression is defined as a period of isoelectric activity in the EEG waveforms.

Time frame
1 week
2

Incidence of Postoperative Delirium (POD)

POD will be diagnosed by our trained research members based on the Confusion Assessment Method (CAM) algorithm postoperatively until discharge.

Time frame
Within 1 week
3

Cognitive function

Postoperative cognitive dysfunction at 1- and 6- months will be assessed with telephone version of the Montreal Cognitive Assessment (t-MoCA) with a maximum positive score of 22. The higher the score, the better the patient's cognitive function.

Time frame
1 month and 6 months
4

Hemodynamic stability - Vasopressor Usage

Metrics of total vasopressor dose in norepinephrine equivalents

Time frame
1 week

Other outcomes

Sponsors and contacts

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