We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Taking Brain Monitoring to the Next Level (HDBRAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04246320
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
Susana Vacas, MD, PhD, University of California, Los Angeles

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).

Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Postoperative Delirium Obstructive Sleep Apnea Other: Goal directed therapy (GDT) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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).




Primary Outcome Measures :
  1. Postoperative cognitive dysfunction [ Time Frame: Preoperatively (within 15 days of surgery) ]
    Montreal Cognitive Assessment (MoCA) test

  2. Postoperative cognitive dysfunction [ Time Frame: postoperatively at discharge (within 2 weeks of surgery). ]
    Montreal Cognitive Assessment (MoCA) test

  3. Postoperative cognitive dysfunction [ Time Frame: 6 months after surgery. ]
    Montreal Cognitive Assessment (MoCA) test

  4. Postoperative Delirium [ Time Frame: Daily for up to 3 days postoperatively ]
    Confusion Assessment Method (CAM-ICU)


Secondary Outcome Measures :
  1. 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

  2. Examining brain changes II [ Time Frame: postoperatively within 2 weeks of surgery ]
    Using non-invasive magnetic resonance imaging based diffusion tensor imaging

  3. Examining brain changes III [ Time Frame: 6 months post surgery ]
    Using non-invasive magnetic resonance imaging based diffusion tensor imaging

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Jennifer Scovotti, MA 310.206.4484 jscovotti@mednet.ucla.edu

Locations
Layout table for location information
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    jscovotti@mednet.ucla.edu   
Principal Investigator: Susana Vacas, MD, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Susana Vacas, MD, PhD University of California, Los Angeles
Publications:
Layout table for additonal information
Responsible Party: Susana Vacas, MD, PhD, Assistant Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04246320    
Other Study ID Numbers: HDBRAIN 16-001040
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Susana Vacas, MD, PhD, University of California, Los Angeles:
goal directed therapy (GDT)
magnetic resonance imaging (MRI)
neurocognitive testing
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea, Obstructive
Postoperative Cognitive Complications
Cognitive Dysfunction
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Postoperative Complications
Pathologic Processes