Taking Brain Monitoring to the Next Level

Obstructive Sleep Apnea Clinical Trial

— HDBRAIN  

Official title:

Taking Brain Monitoring to the Next Level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246320
• Other study ID #: HDBRAIN 16-001040
• Status: Completed
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: August 13, 2022

Study information

• Verified date: January 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 13, 2022
• Est. primary completion date: August 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Obstructive Sleep Apnea
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Postoperative Delirium
• Sleep Apnea, Obstructive

Intervention

Other:
• Goal directed therapy (GDT)
Goal directed therapy (GDT) hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative cognitive dysfunction	Montreal Cognitive Assessment (MoCA) test	Preoperatively (within 15 days of surgery)
Primary	Postoperative cognitive dysfunction	Montreal Cognitive Assessment (MoCA) test	postoperatively at discharge (within 2 weeks of surgery).
Primary	Postoperative cognitive dysfunction	Montreal Cognitive Assessment (MoCA) test	6 months after surgery.
Primary	Postoperative Delirium	Confusion Assessment Method (CAM-ICU)	Daily for up to 3 days postoperatively
Secondary	Examining brain changes	Using non-invasive magnetic resonance imaging based diffusion tensor imaging	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
Secondary	Examining brain changes II	Using non-invasive magnetic resonance imaging based diffusion tensor imaging	postoperatively within 2 weeks of surgery
Secondary	Examining brain changes III	Using non-invasive magnetic resonance imaging based diffusion tensor imaging	6 months post surgery
Secondary	Blood anti-inflammatory biomarkers	Assess blood inflammatory biomarkers (Il6, Il10, TNFa, IL1b, HMGB1) in OSA subjects and non-OSA subjects	pre-operatively (within 15 days before surgery)
Secondary	Blood anti-inflammatory biomarkers	Assess blood inflammatory biomarkers (Il6, Il10, TNFa, IL1b, HMGB1) in OSA subjects and non-OSA subjects	post-operatively (within 2 days of surgery)