Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
NCT Number: NCT03879850
The investigators aim to identify preoperative Electroencephalogram (EEG) markers indicating patients at risk to develop postoperative delirium (POD), so that the anesthetist may adjust medications and dosages in order to avoid POD. Second, the investigators aim to specify intraoperative EEG signatures and EEG states that are related to POD and long-term cognitive dysfunction, again to enable physicians to adapt their procedure. Third, the investigators aim to identify EEG signatures during stay in the recovery room that is directly related to POD, and may therefore be used as diagnostic tool, as well as a predictor for the development of long-term cognitive deficits (POCD).
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Notify Me70 year and older
All sexes
Observational
Berlin, 13353, Germany
The investigators conduct this observational study to identify pre-, intra- and postoperative Electroencephalogram (EEG) signatures / intraoperative EEG states related to postoperative delirium (POD) and postoperative cognitive deficit (POCD) in elderly patients > 70 years. This includes the following tasks at five different time-points
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Patients will be follow until hospital discharge, or maximal until postoperative day 5
Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
Time frame: Patients will be follow until hospital discharge, or maximal until postoperative day 5
Postoperative delirium rate, defined according to ≥ 2 cumulative points in the nursing Delirium Screening Scale (Nu-DESC)
Time frame: Patients will be followed on intensive care unit until hospital discharge, or maximal until postoperative day 5
Postoperative delirium rate, defined according to positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score
Time frame: Patients will be followed on peripheral ward until hospital discharge, or maximal until postoperative day 5
Postoperative delirium rate, defined according to positive Confusion Assessment Method (CAM)
Time frame: Up to 3 months
POCD will be measured by a defined Cambridge Neuropsychological Test Automated Battery (CANTAB) on the day before the operation and after 3 months
Time frame: Up to 3 months
POCD will be measured by Mini Mental State Examination (MMSE) on the day before the Operation, on day 5 and after 3 months
Time frame: Up to 3 months
Neurocognitive Disorder is evaluated according to DSM-V (postoperative cognitive deficit, activities of daily living, instrumental activities of daily living, subjective memory sensing.
Time frame: Up to 5 days
POCD will be measured by Nürnberger-Altersinventar-Test - word pair recognition test on the day before the operation, day 1 ,3 and 5
Time frame: Up to discharge from the recovery room
Bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), Spectral analysis by Matlab code
Time frame: Up to discharge from the recovery room
Postoperative bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), Spectral analysis by Matlab code
Time frame: During anesthesia procedure
Intraoperative bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), raw EEG analysis
Time frame: During anesthesia procedure
Intraoperative pain monitoring is measured by Nociception Level Index (NOL
Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Postoperative duration of delirium, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Postoperative duration of delirium, defined according to Nursing Delirium Screening Scale (Nu-DESC)
Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Postoperative duration of delirium, defined according to Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)Confusion Assessment Method (CAM), Chart Review
Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Postoperative duration of delirium, defined according to Confusion Assessment Method (CAM)
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Intensive care unit length of staywill be assessed by chart review at hospital discharge.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Hospital length of stay will be assessed by chart review at 3 months.
Time frame: Up to 3 months
Mortality will be assessed by chart review at 3 months.
Charite University, Berlin, Germany
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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