Observational Study on the Predictive Value of the BAMCOG and Cortisol Levels for the Incidence of Postoperative Delirium/Postoperative Acute Encephalopathy Measured by the MoCA and the DeltaScan in Patients Who Undergo Aortic Valve Replacement Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Prognostic value of the preoperative BAMCOG to predict postoperative delirium
Study Overview
Brief Summary
There is lack of attention to preoperative cognitive function and delirium in elderly who underwent surgery. The investigators are investigating different tools that can help to screen for cognitive dysfunction and delirium in the future.
Detailed Description
Background of the study:
The mean age of surgical patients is rising worldwide and this is associated with more multi-morbidity. Especially geriatric patients who undergo surgery have a higher risk to develop Postoperative Cognitive Dysfunction or a Postoperative Delirium, which leads to higher morbidity and mortality after surgery and this leads to higher healthcare costs.
A delirium is an acutely disturbed state of mind characterized by restlessness, illusions, and incoherence, occurring in intoxication, fever, and other disorders and can fluctuate over time. The hypoactive delirium, the most common type of delirium, is hard to recognize compared to the active delirium that is expressed by restlessness and agitation.
Postoperative cognitive dysfunction is defined as a new cognitive impairment arising after a surgical procedure. Its diagnosis requires both pre- and postoperative psychometric testing. Its manifestations are subtle and manifold, depending on the particular cognitive domains that are affected, and therefore hard to recognize too.
To assess preoperative cognitive function in large groups of patients, it's needed to have a simple and quick tool to screen. In this study, the investigators use the BAMCOG, which is a tool with 3 short games played on a tablet that can provide information about cognitive functioning. When writing this new study protocol, a validation study in which the BAMCOG is validated against the MoCA is running.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to 120 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age >65 year
- •scheduled for AVR surgery
- •Able to play the BAMCOG games after instruction
- •(Near) native (dutch)
Exclusion Criteria
- •mental disorder
- •learning disorder
- •diagnosed dementia at start of study
- •alcohol abuses
- •lithium/clozapine use because of DeltaScan
- •sedation/RASS -4/-5 because of DeltaScan
- •not able to sign informed consent
- •implanted pacemaker, defibrillator or neurostimulator because of pilocarpine iontophoresis
- •history of insults
- •pregnant women
- •allergy to pilocarpine
- •damaged skin (forearm)
Outcomes
Primary Outcomes
Prognostic value of the preoperative BAMCOG to predict postoperative delirium
Time Frame: BAMCOG and DeltaScan - preoperative 1 day, postoperative day 1, 3, 7.
Secondary Outcomes
- Correlation BAMCOG scores and MoCA scores(MoCA - preoperative 1 day, postoperative day 1, 3, 7)
- Prognostic value of cortisol measures (Sweat, Saliva, Serum) to predict postoperative delirium(Preoperative at home and postoperative day 1)
Investigators
Mariska te Pas
Principal Investigator
Catharina Ziekenhuis Eindhoven