The purpose of this international, multi-centre observational study is to describe perioperative cognitive changes (pre-existing neurocognitive disorder \[NCD\], postoperative delirium \[POD\] and Postoperative Cognitive Dysfunction \[POCD\]) up to five years after elective surgery in a mixed cohort. Measurements and definitions of cognitive outcomes will be based on current consensus and used for further harmonization in future clinical studies on perioperative cognitive trajectories. This is a feasibility approach to identify an effective screening procedure and estimate loss to follow up rates for the planning of future intervention studies. Data from this trial may also serve to facilitate and implement time effective cognitive screening and risk stratification concerning postoperative cognitive decline in the anaesthesiological preoperative assessment.
This international observational study on perioperative cognitive trajectories (POCD census international/PCI) has been designed as a pilot study to allow a peer reviewed process of four international test centres on measurement of perioperative acute and long-term cognitive outcome. Data from standard clinical treatment of 500 patients age ≥ 70 years scheduled for elective surgery (stratified according to preoperative assessment of frailty and monitored by intraoperative depth of anaesthesia) will be supplemented by guideline conform delirium- analgesia- and sedation screening until day 5 after surgery, I-Pad based neuropsychological testing \[Cambridge Neuropsychological Test Automated Battery - CANTAB connect\] pre-operatively, 3 months, 1- 2- and 5 years after surgery, a paper-based verbal fluency test (animal naming test from Addenbrooke's Cognitive Examination Revised (ACE-R)), a paper based test on executive function (Trailmaking Test), cognitive screening tests (Montreal Cognitive Assessment (MOCA) and Mini-Cog), and concomitant questionnaires to assess functional status, self- and by proxy rating of cognitive performance, psychological factors (depression, perioperative anxiety, stress, resilience and coping), social support, perioperative anxiety, stress, resilience and coping, as well as risk consumption of alcohol and tobacco. A non-surgical control group of 100 study participants who are not scheduled for surgery will be followed up at the same time points as the surgical cohort for scaling of cognitive data and definition of cut off values to define significant cognitive decline. Secondary outcome measures of this trial comprise levels and changes in molecular biomarkers involved in Alzheimer's dementia etiology sampled from spinal fluid on induction of spinal anaesthesia and sampled from blood in all patients. Retrospective comparison collective (01/01/2017 to 01/01/2022): A group of around 8000 surgical patients aged 65 and older at the Charité will be examined as control group. This control group is required for various questions, especially influencing factors with regard to the postoperative outcome of delirium, and aims to test the predictive ability of clinical routine data with regard to postoperative delirium. As part of the multimodality of this retrospective comparative cohort study, in cooperation with PD. Dr Scheel and in collaboration with Prof. Dr. Finke, cranial MRI scans analyzing routine data from the Institute of Neuroradiology. The subject of the investigation is initially the entire electronic routine data of the control group, including the existing cranial MRI scans.
Study Type
OBSERVATIONAL
Enrollment
173
Arbeitsbereich Physikalische Medizin
Berlin, Germany
Internistische Hausarztpraxis
Berlin, Germany
Department of Anesthesiology and Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, Germany
Incidence of postoperative cognitive dysfunction (POCD)
Neuropsychological testing
Time frame: Up to 1 year
Incidence of postoperative cognitive dysfunction (POCD)
Neuropsychological testing
Time frame: Up to 5 years
Positive cognitive screening
Short neuropsychological testing
Time frame: Up to 5 years
Mild Neurocognitive Disorder
Definition according to DSM-V as proposed in Evered L et al. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery. Br J Anaesth, Anesthesiology, Can J Anesth, Anesth Analg, J Alz Dis, acta scandinavica anaesthesiologica (Joint Publication) 2017; Accepted, In Press. We will use an I-pad based neuropsychological test battery (CANTAB connect), and cognitive screening instruments (MOCA, Mini-Cog™ and Animal naming test on verbal fluency from ACE-R) for assessment of cognitive function, MMQ and IQ-code for self- or by proxy reported cognitive concern and ADL/IADL for assessment of functional status. Mild/major Neurocognitive Disorder measured at baseline (pre-existing NCD) 3 months and 1 year (with specifier 'POCD'), 2- and 5 years after surgery
Time frame: Up to five years
Major Neurocognitive Disorder
Definition according to DSM-V as proposed in Evered L et al. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery. Br J Anaesth, Anesthesiology, Can J Anesth, Anesth Analg, J Alz Dis, acta scandinavica anaesthesiologica (Joint Publication) 2017; Accepted, In Press. We will use an I-pad based neuropsychological test battery (CANTAB connect), and cognitive screening instruments (MOCA, Mini-Cog™ and Animal naming test on verbal fluency from ACE-R) for assessment of cognitive function, MMQ and IQ-code for self- or by proxy reported cognitive concern and ADL/IADL for assessment of functional status. Mild/major Neurocognitive Disorder measured at baseline (pre-existing NCD) 3 months and 1 year (with specifier 'POCD'), 2- and 5 years after surgery
Time frame: Up to five years
Cerobrospinal fluid biomarker for diagnosing dementia
Patients for spinal anesthesia who consented on lumbar puncture receive biomarkers analysis from spinal fluid (beta Amyloid 1-40, beta-Amyloid 1-42, beta-Amyloid Ratio (42/40\*10), phospho-TAU, Protein 14-3-3, PRPSc, TAU (Gesamt-Tau)).
Time frame: Up to five years
Blood biomarker for diagnosing dementia
Patients consented on blood sampling receive biomarker analysis from blood (Apolipoprotein E).
Time frame: Up to five years
Findings of memory consultation session
Time frame: Up to five years
Comorbidities
Comorbidities will be quantified by use of Charlson Comorbidity index
Time frame: Up to five years
Nutritional status
Changes in the nutritional status after elective surgery are measured by a questionnaire.
Time frame: Up to five years
Malnutrition 1
Malnutrition is measured by the Body mass index
Time frame: Up to five years
Malnutrition 2
Malnutrition is measured by weight
Time frame: Up to five years
Malnutrition 3
Malnutrition is measured by weight
Time frame: Up to five years
Dental health
The dental status is determined by tooth doctors
Time frame: Up to five years
Sarcopenia
The composite outcome measure "Sarcopenia" is defined by the following three criteria: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference and 3) low physical performance (gait speed). Criterion (1) identifies probable sarcopenia, additional documentation of criterion (2) confirms sarcopenia diagnosis, and if all criteria (1), (2) and (3) are met, sarcopenia is considered severe.
Time frame: Up to five years
Calf circumference
Calf circumference is measured in a standardized position and documented in centimeter.
Time frame: Up to five years
Arm circumference
Arm circumference is measured in a standardized position and documented in centimeter.
Time frame: Up to five years
Adherence to Mediterranean diet (MD)
Adherence to Mediterranean diet (MD) is measured with a German Mediscore, could range from 0 to 9, with higher scores (6-9) indicating greater MD adherence.
Time frame: Up to five years
Nutrition in the hospital
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Time frame: Up to five years
Physical activity
Physical activity is evaluated by interviewing the Patient.
Time frame: At the beginning of the observation
Surgical risk
Surgical risk will be described by type and length of surgery and perioperative cardiac risk estimation as described in Anästh Intensivmed 2017; 58:349-364.
Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour
Anaesthesiological Risk 1
Anaesthesiological risk will be described by American Society of Anesthesiologists Classification (ASA Class)
Time frame: At the beginning of the observation
Anaesthesiological Risk 2
Anaesthesiological risk will be measured by length of anesthesia
Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour
Anaesthesiological Risk 3
Anaesthesiological risk will be measured by type of anaesthesia
Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour
Intraoperative depth of anaesthesia
Intraoperative depth of sedation will be monitored with changes in the pattern and power spectrum of EEG-raw data measured with the Masimo SedLine® brain function monitoring for Root®, Narcotrend®, BIS™ and additionally quantified by indices \[e.g. PSI or BIS-index\] and burst suppression ratio.
Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour
Depth of sedation on the Intensive Care Unit
Sedation is measured by Richmond Agitation Sedation Scale.
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Sedation on the peripheral ward
Sedation is measured by Richmond Agitation Sedation Scale.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Agitation on the peripheral ward
Agitation describes a clinical state in which the patient may be impulsive and attempt to get out of bed, to wander, and to fall (which may lead to further injury or death) and attempt to remove IV lines, tubes, or catheters.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Incidence of postoperative delirium
Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), CAM/CAM-ICU, Nu-DESC and Chart Review.
Time frame: Up to 5 days
Severity of postoperative delirium
Postoperative delirium rate, defined according to Confusion assessment method - severity(CAM-S); Delirium Rating Scale Revised (DSR-R-98), Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC).
Time frame: Up to 5 days
Duration of Delirium
Duration of postoperative delirium, defined according to medical evaluation, measured in days
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Pain scale for patients able of pain self-assessment
Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V).
Time frame: Up to hospital discharge, an expected average of 5 days
Pain scales for patients unable of pain self-assessment
For patients unable of pain self-assessment (e.g. ventilated patients, patients in delirious state or patients with stroke affecting language skills) observer-rated pain scales will be applied: Behavioural Pain Scale (BPS for ventilated) and BPS-NI (for non-ventilated) patients, Critical-Care Pain Observation Tool (CPOT) during hospital stay.
Time frame: Up to hospital discharge, an expected average of 5 days
Intensive care unit length of stay
Intensive care unit length of stay describes every day spent in an ICU bed.
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Hospital length of stay
Hospital length of stay describes every day spent in an hospital.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Perioperative Anxiety
Perioperative anxiety will be measured with APAIS preoperatively and the Faces Anxiety Scale (FAS) and during hospital stay.
Time frame: Up to 5 days
Perception of stress
Stress is measured by Perceived Stress Questionnaire 20
Time frame: Up to 5 days
Stress level
Stress level is measured by stress thermometer
Time frame: Up to 5 days
Generalized anxiety
Anxiety will be measured with the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: Up to 5 days
Depression
Depression is measured by PHQ-8. Scores represent:0-5 = mild, 6-10 = moderate, 11-15 = moderately severe, 16-20 = severe depression
Time frame: Up to 5 years
Quality of sleep
Quality of sleep is measured by the Insomnia Severity Index.
Time frame: Up to 5 years
Routine laboratory
Time frame: Up to hospital discharge, an expected average of 7 days
Organ dysfunctions
Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications
Time frame: Up to hospital discharge, an expected average of 7 days
Subjective/By proxy assessment of cognitive impairment
Time frame: Up to five years
Medication
Prescribed regular drug intake from baseline at all follow ups including perioperative application of drugs, infusions and transfusions will be evaluated.
Time frame: Up to 5 years
Quality of life
Quality of life will be measured with the EQ-5D-5L
Time frame: Up to 5 years
Level of dependency
Level of dependency will be measured with with ADL/IADL, single items concerning patients' living situation and the BSSS-17 (Berlin Social Support Scales).
Time frame: Up to 5 years
Plausibility check variables
Variables affecting performance of cognitive testings
Time frame: Up to 5 years
Re-admission
Hospital readmission is an episode when a patient who had been discharged from a hospital is admitted again within a specified time interval.
Time frame: Up to 5 years
Revison surgery
Surgery performed to replace or compensate for a failed implant or to correct undesirable sequelae of previous surgery.
Time frame: Up to 5 years
Outpatient treatment
Treatment outside of the hospital in an associated facility for diagnosis or treatment.
Time frame: Up to 5 years
Mortality
The number of deaths in a given period.
Time frame: Up to 5 years
Dementia
Dementia reported as clinical diagnosis based on DSM-5 criteria for major NCD either through neuropsychological evaluation at a memory clinic or as a research diagnosis based on neuropsychological test values (CANTAB/MOCA), cognitive concern (MMQ/IQCODE) and functionality (ADL/IADL).
Time frame: Up to 5 years
Motivational incongruence
The incongruence questionnaire (Der Inkongruenzfragebogen)
Time frame: Up to five years
Leisure behavior
Questionnaire on frequency of cognitively stimulating leisure activities
Time frame: Up to five years
Demographic variables
Time frame: Up to five years
Living conditions
Time frame: Up to five years
Postoperative electroencephalography (EEG) spectral analysis with band power
Spectral analysis with band power are measured by EEG at third postoperative day and delirium dependent until postoperative day 7.
Time frame: Up to seven days
Evaluation of pain
Pain is measured with dolosys paintracker
Time frame: Up to three months
Loneliness
Loneliness is measured with the UCLA-Loneliness-Scale (3 items)
Time frame: Up to five years
Social support
Social support is measured with the Berliner Social-Support Skalen BSSS-17
Time frame: Up to five years
Living situation
Living situation is measured with te question: How do you live?
Time frame: Up to five years
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