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Cerebral Oxygenation and Neurological Functioning After Cardiac Surgery (CONFUSE)

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ClinicalTrials.gov Identifier: NCT04081649
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Gordon Boyd, Queen's University

Brief Summary:
The overall goal of this research program is to determine quantitative predictors of quantitative long-term neurological functioning following different cardiac surgery procedures. The investigators aim to generate a timeline of neurological function that includes pre-existing performance, post-operative delirium, and neurological outcome. Furthermore, the investigators will test the hypothesis that intraoperative regional cerebral oxygenation (rSO2) desaturations, as measured by near-infrared spectroscopy (NIRS) are associated with poor neurological functioning following cardiac surgery, as measured by a robotic device called the KINARM.

Condition or disease
Coronary Artery Disease Cognitive Impairment Delirium

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Study Type : Observational
Estimated Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oxygenation and Neurological Functioning After Cardiac Surgery
Actual Study Start Date : June 1, 2014
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort
Cardiac surgery
Patients undergoing non-emergent cardiac surgery for coronary bypass graft and/or valvular replacement



Primary Outcome Measures :
  1. 12 month cognitive outcome-Repeatable Battery of Neuropsychological Status (RBANS) Total Scale [ Time Frame: 12 months ]
    Participants will be assessed with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS assesses 5 cognitive domains (language, visuospatial, immediate memory, delayed memory, and attention). The individual domain scores are compiled to provide at total cognitive score (Total Scale), which is age-adjusted. The population normative value is 100 +/- 24 (1.96 SD).

  2. 12 month cognitive outcome-KINARM robotic assessment-visually guided reaching [ Time Frame: 12 months ]
    This centre-out reaching task assesses basic visuospatial skills and sensorimotor control. The subject's hand is represented by a white dot. Each subject is then instructed to bring the white dot quickly and accurately to the red target as they appear on the screen. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.

  3. 12 month cognitive outcome-KINARM robotic assessment-arm position matching [ Time Frame: 12 months ]
    Patients are instructed to mirror-match the movement and final position of the robot-controlled arm. This task is performed twice to obtain data on both arms. Patients will require intact proprioceptive functioning to process information on where their limb is in the horizontal space. This arm position matching task has been shown to determine the degree of position sense impairment in subjects following stroke. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.

  4. 12 month cognitive outcome-KINARM robotic assessment-reverse visually guided reaching [ Time Frame: 12 months ]
    This task is presented similarly to the visual guided reaching task. However, the movement of the white dot is now reversed compared to the movement of the patient's hand. To successfully complete the task, patients must move their hand away from the target, thereby reaching the red target with the white dot. This is a more complex reaching task, requiring inhibitory control to not automatically reach towards the red target and a cognitive rule to move the white cursor by moving in the opposite direction. Visuomotor impairments of this nature have been described in individuals at risk of developing Alzheimer's disease. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.

  5. 12 month cognitive outcome-KINARM robotic assessment-ball on bar [ Time Frame: 12 months ]
    Patients are instructed to use a virtual bar, generated between their hands, to balance a virtual ball as it appears on the screen. The subject must then bring the balanced ball on bar to different target locations in virtual space. This task consists of three levels: 1) ball fixed to bar, 2) ball moves along bar based on bar orientation, 3) ball can roll freely along bar. This task assesses bimanual motor control. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.

  6. 12 month cognitive outcome-KINARM robotic assessment-object hit [ Time Frame: 12 months ]
    In this task, the participants' hands are represented by paddles. Subjects are instructed to hit balls falling down from the top of the screen towards them. As the task progresses, the balls begin to fall more frequently and increase in speed, making the task gradually more difficult. This simple task measures sensorimotor function and decision-making. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.

  7. 12 month cognitive outcome-KINARM robotic assessment-object hit and avoid [ Time Frame: 12 months ]
    This task is similar to the object hit task, where patients use the robot's handles to hit objects falling from the top of the screen towards them. In this task however, patients are instructed to only hit two target shapes while avoiding all other shapes (i.e distractors). The Object hit & avoid task therefore requires additional cognitive functions related to attention to identify each shape and inhibitory control to avoid the distractors. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.

  8. 12 month cognitive outcome-KINARM robotic assessment-spatial span [ Time Frame: 12 months ]
    A series of squares light up on the screen in a particular sequence. Within a 3-by-4 grid of squares, patients are required to replay the sequence by reaching with their dominant hand to the correct squares. This task assesses visuospatial working memory, and is similar to the Corsi block-tapping task. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.

  9. 12 month cognitive outcome-KINARM robotic assessment-trail making [ Time Frame: 12 months ]
    This task is a quantitative version of the standard pen-and-paper neuropsychological test. In trailing making part A, patients are instructed to connect the numbers 1 through 25. The trail making part B task requires subjects to connect the dots by alternating numbers and letters (1-A-2-B-3-C, etc.). This task assesses executive function related to task switching. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.


Secondary Outcome Measures :
  1. Cognitive trajectory (changes in KINARM and RBANS performance from pre-surgery, to 3- and 12-months post-operative) [ Time Frame: Pre-operative, 3 months post-operative, and 12-months post-operative ]
    This will be assessed with the KINARM robot and the RBANS (described above)

  2. Physiological determinants of rSO2 [ Time Frame: Intraoperative (3-6 hours) ]
    Intraoperative hemodynamic and physiological variables will be collected during the operation (eg. mean arterial pressure (mmHg), heart rate (beats per minute), peripheral oxygen saturation (%)) to determine the predictors of rSO2. A linear model will be created to demonstrate the relative contribution each of these predictors has to cerebral oxygenation (rSO2-single outcome variable).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient undergoing non-emergent surgery will be recruited from the perioperative assessment clinic by a trained researcher.
Criteria

Inclusion Criteria:

  • adult patients undergoing coronary artery bypass surgery +/- valvular surgery

Exclusion Criteria:

  • pre-existing cognitive impairment or neurodegenerative condition
  • any reason that participant cannot participate in follow up (lives too far away, limb amputation, speaks language other than english)

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): NCT04081649


Contacts
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Contact: J. Gordon Boyd, MD, PhD 6135392754 2jgb1@queensu.ca

Locations
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Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L3V7
Contact: John G Boyd, MD, PhD    613-549-6666 ext 6228    2jgb1@queensu.ca   
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: J. Gordon Boyd, MD, PhD Queen's University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Gordon Boyd, Associate Professor, Queen's University
ClinicalTrials.gov Identifier: NCT04081649    
Other Study ID Numbers: DMED-1672-14
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will be willing to share IPD following the publication of our study in peer reviewed literature.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Following publication of our study, our data will be available for 5 years.
Access Criteria: Study PI can be contacted via email for data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases