Taking Brain Monitoring to the Next Level (HDBRAIN)
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|ClinicalTrials.gov Identifier: NCT04246320|
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : May 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Cognitive Dysfunction Postoperative Delirium Obstructive Sleep Apnea||Other: Goal directed therapy (GDT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Taking Brain Monitoring to the Next Level|
|Actual Study Start Date :||January 30, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||June 30, 2023|
Patients monitored and receiving a standard anesthesia plan in addition of a goal directed therapy (GDT) hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).
Other: Goal directed therapy (GDT)
Goal directed therapy (GDT) hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).
- Postoperative cognitive dysfunction [ Time Frame: Preoperatively (within 15 days of surgery) ]Montreal Cognitive Assessment (MoCA) test
- Postoperative cognitive dysfunction [ Time Frame: postoperatively at discharge (within 2 weeks of surgery). ]Montreal Cognitive Assessment (MoCA) test
- Postoperative cognitive dysfunction [ Time Frame: 6 months after surgery. ]Montreal Cognitive Assessment (MoCA) test
- Postoperative Delirium [ Time Frame: Daily for up to 3 days postoperatively ]Confusion Assessment Method (CAM-ICU)
- Examining brain changes [ Time Frame: 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 ]Using non-invasive magnetic resonance imaging based diffusion tensor imaging
- Examining brain changes II [ Time Frame: postoperatively within 2 weeks of surgery ]Using non-invasive magnetic resonance imaging based diffusion tensor imaging
- Examining brain changes III [ Time Frame: 6 months post surgery ]Using non-invasive magnetic resonance imaging based diffusion tensor imaging
- Blood anti-inflammatory biomarkers [ Time Frame: pre-operatively (within 15 days before surgery) ]Assess blood inflammatory biomarkers (Il6, Il10, TNFa, IL1b, HMGB1) in OSA subjects and non-OSA subjects
- Blood anti-inflammatory biomarkers [ Time Frame: post-operatively (within 2 days of surgery) ]Assess blood inflammatory biomarkers (Il6, Il10, TNFa, IL1b, HMGB1) in OSA subjects and non-OSA subjects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246320
|Contact: Jennifer Scovotti, MAfirstname.lastname@example.org|
|United States, California|
|Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Jennifer Scovotti, MA 310-206-4484 email@example.com|
|Principal Investigator: Susana Vacas, MD, PhD|
|Principal Investigator:||Susana Vacas, MD, PhD||University of California, Los Angeles|