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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04246320
Recruitment Status : Completed
First Posted : January 29, 2020
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Rajesh Kumar, PhD, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE January 23, 2020
First Posted Date  ICMJE January 29, 2020
Last Update Posted Date January 19, 2023
Actual Study Start Date  ICMJE January 30, 2020
Actual Primary Completion Date August 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • 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 ofsurgery ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Taking Brain Monitoring to the Next Level
Official Title  ICMJE Taking Brain Monitoring to the Next Level
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Postoperative Cognitive Dysfunction
  • Postoperative Delirium
  • Obstructive Sleep Apnea
Intervention  ICMJE Other: Goal directed therapy (GDT)
Goal directed therapy (GDT) hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).
Study Arms  ICMJE 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).
Intervention: Other: Goal directed therapy (GDT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2023)
7
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2020)
60
Actual Study Completion Date  ICMJE August 13, 2022
Actual Primary Completion Date August 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04246320
Other Study ID Numbers  ICMJE HDBRAIN 16-001040
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Rajesh Kumar, PhD, University of California, Los Angeles
Original Responsible Party Susana Vacas, MD, PhD, University of California, Los Angeles, Assistant Professor-in-Residence
Current Study Sponsor  ICMJE University of California, Los Angeles
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rajesh Kumar, PhD University of California, Los Angeles
Principal Investigator: Susana Vacas, M.D., Ph.D. Massachusetts General Hospital
PRS Account University of California, Los Angeles
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP