Preoperative BAMCOG and Cortisol and Postoperative DeltaScan in AVR Patients (Aortic Valve Replacement)

NCT05209555 | Completed DMC

• 1 other identifier: CZE-2021.57
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Cognitive Impairment; Cognitive Dysfunction; Cognitive Dysfunction, Postoperative; Delirium in Old Age; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Prognostic value of the preoperative BAMCOG to predict postoperative delirium

  BAMCOG and DeltaScan - preoperative 1 day, postoperative day 1, 3, 7.

Secondary Outcomes (2)

• 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

Interventions

MoCA DIAGNOSTIC_TEST

MoCA test to identify Mild Cognitive Impairment

BAMCOG DEVICE

Three games, compared to the MoCA to identify Mild Cognitive Impairment

DeltaScan DIAGNOSTIC_TEST

EEG to detect acute encephalopathy

Salivette DIAGNOSTIC_TEST

To collect saliva for cortisol analysis

Pilocarpine iontophoresis DIAGNOSTIC_TEST

To collect sweat for cortisol analysis

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 patients 65 years or older who will undergo AVR-bio surgery

You may qualify if:

• age \>65 year
• scheduled for AVR surgery
• Able to play the BAMCOG games after instruction
• (Near) native (dutch)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Hospital

Eindhoven, Netherlands

Location

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications; Emergence Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 26, 2022
• Study Start: January 10, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)