Clinical trial NCT04246320: Taking Brain Monitoring to the Next Level
Official title: Taking Brain Monitoring to the Next Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Postoperative Delirium
Obstructive Sleep Apnea
Keywords: goal directed therapy (GDT)
magnetic resonance imaging (MRI)
neurocognitive testing
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 7
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This one arm clinical study will assess the impact of a goal directed therapy intervention, aiming at optimizing depth of anesthesia and intraoperative blood pressure on the incidence of postoperative cognitive dysfunction and delirium relative to a standardized anesthetic plan. We will enroll 60 patients and will measure the neurocognitive status (MoCA test) of patients before and after surgery (at discharge, within 2 weeks after surgery and 6 months after surgery) to determine the relative impact of anesthetic care on the development of postoperative delirium and cognitive decline. All patients will have a brain scan (fMRI) before and after surgical intervention. Patients will also be asked to participate in an optional blood draw which will take place during their brain imaging visit and post operatively (within 2 days after surgery).

Detailed description: This study will test the hypothesis that a goal directed therapy intervention, which optimizes depth of anesthesia and intraoperative blood pressure can decrease the incidence of postoperative neurocognitive dysfunction

Subjects will be recruited for the study and the protocol explained. In addition to standard American Society of Anesthesiologists (ASA) monitoring, we will monitor continuous non-invasive blood pressure and 4 lead electroencephalogram (EEG) channels. Patients will receive standardized anesthesia care in addition to a goal directed therapy hemodynamic management (MAP \> 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).

Neurocognitive testing: In order to assess general cognitive function, the Montreal Cognitive Assessment test will be used. Cognitive function will be measured preoperatively and postoperatively at discharge, 1 month and 6 months after surgery. For delirium measurement, we will administer daily the Confusion Assessment Method (CAM-ICU) for up to 3 days.

The Montreal Cognitive Assessment (MoCA) is a screening tool to assess mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructionals skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.

The Wide Range Assessment of Memory and Learning (WRAML2) is a broad-based memory battery that provides a flexible measure of memory functioning and learning and takes approximately 45-60 minutes to administer. This assessment will be conducted at the first MRI visit and at the 6 month follow up.

The Confusion Assessment Method for the ICU (CAM-ICU) screens for the development of delirium and assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The CAM-ICU is positive, and the patient is considered to have delirium, if features 1 and 2 and either feature 3 or 4 are present.

Brain imaging: The timing of pre-operative brain imaging will be as allowed by patient factors and scanner availability, typically less than 15 days before surgery, when the patient comes for the preoperative evaluation, and postoperatively within 2 weeks after surgery.

Optional Blood Draws: Patients will be asked to provide 2 optional blood samples, drawn the day of their brain imaging visit and post-operatively (within 2 days). These samples will be used to asses blood inflammatory biomarkers in obstructive sleep apnea (OSA) subjects and non-OSA subjects between baseline and post-surgery.

Eligibility criteria: Inclusion Criteria:

* 45-75 years old,
* undergoing abdominal, orthopedic, gynecological, or urological surgery
* expected to stay in hospital for at least 24hours

Exclusion Criteria:

* Substantial hearing impairment or inability to understand English, since there needs to be neurocognitive testing done
* status post craniotomy
* severe dementia

Primary outcomes:
measure: Postoperative cognitive dysfunction
timeFrame: Preoperatively (within 15 days of surgery)
measure: Postoperative cognitive dysfunction
timeFrame: postoperatively at discharge (within 2 weeks of surgery).
measure: Postoperative cognitive dysfunction
timeFrame: 6 months after surgery.
measure: Postoperative Delirium
timeFrame: Daily for up to 3 days postoperatively
Secondary outcomes:
measure: Examining brain changes
timeFrame: Typically less than 15 days before surgery, when the patient comes for the preoperative evaluation, postoperatively at up to 48 hours after surgery, and 6 months post surgery
measure: Examining brain changes II
timeFrame: postoperatively within 2 weeks of surgery
measure: Examining brain changes III
timeFrame: 6 months post surgery
measure: Blood anti-inflammatory biomarkers
timeFrame: pre-operatively (within 15 days before surgery)
measure: Blood anti-inflammatory biomarkers
timeFrame: post-operatively (within 2 days of surgery)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Rajesh Kumar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Susana Vacas, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joosten A, Rinehart J, Bardaji A, Van der Linden P, Jame V, Van Obbergh L, Alexander B, Cannesson M, Vacas S, Liu N, Slama H, Barvais L. Anesthetic Management Using Multiple Closed-loop Systems and Delayed Neurocognitive Recovery: A Randomized Controlled Trial. Anesthesiology. 2020 Feb;132(2):253-266. doi: 10.1097/ALN.0000000000003014.
citation: Vacas S, Cannesson M. Noninvasive Monitoring and Potential for Patient Outcome. J Cardiothorac Vasc Anesth. 2019 Aug;33 Suppl 1(Suppl 1):S76-S83. doi: 10.1053/j.jvca.2019.03.045. No abstract available.