Clinical trial NCT04081649: Cerebral Oxygenation and Neurological Functioning After Cardiac Surgery
Official title: Cerebral Oxygenation and Neurological Functioning After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Cognitive Impairment
Delirium
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient undergoing non-emergent surgery will be recruited from the perioperative assessment clinic by a trained researcher.

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.


Eligibility 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)

Primary outcomes:
measure: 12 month cognitive outcome-Repeatable Battery of Neuropsychological Status (RBANS) Total Scale
timeFrame: 12 months
measure: 12 month cognitive outcome-KINARM robotic assessment-visually guided reaching
timeFrame: 12 months
measure: 12 month cognitive outcome-KINARM robotic assessment-arm position matching
timeFrame: 12 months
measure: 12 month cognitive outcome-KINARM robotic assessment-reverse visually guided reaching
timeFrame: 12 months
measure: 12 month cognitive outcome-KINARM robotic assessment-ball on bar
timeFrame: 12 months
measure: 12 month cognitive outcome-KINARM robotic assessment-object hit
timeFrame: 12 months
measure: 12 month cognitive outcome-KINARM robotic assessment-object hit and avoid
timeFrame: 12 months
measure: 12 month cognitive outcome-KINARM robotic assessment-spatial span
timeFrame: 12 months
measure: 12 month cognitive outcome-KINARM robotic assessment-trail making
timeFrame: 12 months
Secondary outcomes:
measure: Cognitive trajectory (changes in KINARM and RBANS performance from pre-surgery, to 3- and 12-months post-operative)
timeFrame: Pre-operative, 3 months post-operative, and 12-months post-operative
measure: Physiological determinants of rSO2
timeFrame: Intraoperative (3-6 hours)
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: J. Gordon Boyd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Semrau JS, Scott SH, Hamilton AG, Petsikas D, Payne DM, Bisleri G, Saha T, Boyd JG. Road to recovery: a study protocol quantifying neurological outcome in cardiac surgery patients and the role of cerebral oximetry. BMJ Open. 2019 Dec 3;9(12):e032935. doi: 10.1136/bmjopen-2019-032935.