An observational study in Cognitive Dysfunction, sponsored by Neuroindex Ltd.. Status unknown at 1 site in Israel. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by Neuroindex Ltd. · Observational
Cognitive complications after major surgery are a common phenomenon. The incidence of Postoperative Cognitive Dysfunction (POCD), may vary from 5% to 25% in adult patients, depending on different risk factors. Age has been strongly associated with cognitive complications. POCD is a prolonged decline in cognitive function that appears after surgery as compared with preoperative functions. In order to classify evaluate POCD, it requires at least 2 measurements. A baseline, completed before surgery and a second measurement, post surgery.
In light of the high prevalence of POCD and the difficulties in its prediction, NeuroIndex has developed a quantitative EEG system and software that aim to produces risk predictor index (IS) for POCD. This study aims to evaluate the relationship between the software produced predictor index and the actual POCD events. The qEEG will be monitored during the surgery in addition to the routine clinical practice in operating rooms.
POCD will be evaluated using Montreal Cognitive Assessment test (MoCA) prior and post surgery.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 418 observational studies indexed under Delirium.
Browse Delirium studies →This is the only study on the registry with Neuroindex Ltd. as lead sponsor.
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The study population will consist of male and female adults undergoing cardiac surgery under general anesthesia
Exclusion Criteria:
Patients over 65 years undergoing heart surgery under anesthesia, EEG monitored
Device: EEG monitoring
EEG monitoring under general anesthesia
The qEEG parameter IS correlation with POCD
The qEEG parameter IS, which range between 0 and 1, where higher scores are more favorable than lower scores will be evaluated for its correlation with POCD that will be measured by Montreal Cognitive Assessment (MoCA)
Time frame: 1 week following surgery
Plan to share: No
No publications or documents are linked to this record.
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