International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)
- Conditions
- Postoperative Cognitive Deficit (POCD)Neurocognitive Disorders
- Registration Number
- NCT03540433
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
- Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
- Aged ≥ 70 years
- Informed consent
- Manifest dementia
- Lack of willingness to store and disseminate pseudonymized disease data as part of the clinical trial
- Lack of readiness to participate in the follow-up examinations and contact to make an appointment
- Placement in an institute under judicial or official orders (according to German drug Law §40 (1) 4)
- Persons without a permanent residence or other circumstances that call into question the availability by telephone or post for postoperative examination
- Employees of the respective study centers
- illiteracy
- Patients with a neuropsychiatric condition that limits the performance of neurocognitive testing
- Patients with hearing and / or vision problems that limit the performance of neuro-cognitive testing
- Simultaneous participation in a prospective clinical intervention study (apart from the desired parallel participation in the anaesthesiological study Praep-Go, EA1/225/19)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of postoperative cognitive dysfunction (POCD) Up to 1 year Neuropsychological testing
- Secondary Outcome Measures
Name Time Method Demographic variables Up to five years Blood biomarker for diagnosing dementia Up to five years Patients consented on blood sampling receive biomarker analysis from blood (Apolipoprotein E).
Incidence of postoperative cognitive dysfunction (POCD) Up to 5 years Neuropsychological testing
Positive cognitive screening Up to 5 years Short neuropsychological testing
Cerobrospinal fluid biomarker for diagnosing dementia Up to five years 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)).
Nutritional status Up to five years Changes in the nutritional status after elective surgery are measured by a questionnaire.
Findings of memory consultation session Up to five years Comorbidities Up to five years Comorbidities will be quantified by use of Charlson Comorbidity index
Sarcopenia Up to five years 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.
Physical activity At the beginning of the observation Physical activity is evaluated by interviewing the Patient.
Sedation on the peripheral ward Participants will be followed for the duration of hospital stay, an expected average of 7 days Sedation is measured by Richmond Agitation Sedation Scale.
Major Neurocognitive Disorder Up to five years 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
Malnutrition 1 Up to five years Malnutrition is measured by the Body mass index
Malnutrition 3 Up to five years Malnutrition is measured by weight
Arm circumference Up to five years Arm circumference is measured in a standardized position and documented in centimeter.
Adherence to Mediterranean diet (MD) Up to five years 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.
Surgical risk Participants will be followed up during surgery, an estimated duration of 1 hour 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.
Anaesthesiological Risk 2 Participants will be followed up during surgery, an estimated duration of 1 hour Anaesthesiological risk will be measured by length of anesthesia
Duration of Delirium Participants will be followed for the duration of hospital stay, an expected average of 7 days Duration of postoperative delirium, defined according to medical evaluation, measured in days
Mild Neurocognitive Disorder Up to five years 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
Nutrition in the hospital Up to five years Participants will be followed for the duration of hospital stay, an expected average of 7 days
Intraoperative depth of anaesthesia Participants will be followed up during surgery, an estimated duration of 1 hour 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.
Intensive care unit length of stay Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days Intensive care unit length of stay describes every day spent in an ICU bed.
Hospital length of stay Participants will be followed for the duration of hospital stay, an expected average of 7 days Hospital length of stay describes every day spent in an hospital.
Perioperative Anxiety Up to 5 days Perioperative anxiety will be measured with APAIS preoperatively and the Faces Anxiety Scale (FAS) and during hospital stay.
Perception of stress Up to 5 days Stress is measured by Perceived Stress Questionnaire 20
Level of dependency Up to 5 years Level of dependency will be measured with with ADL/IADL, single items concerning patients' living situation and the BSSS-17 (Berlin Social Support Scales).
Mortality Up to 5 years The number of deaths in a given period.
Loneliness Up to five years Loneliness is measured with the UCLA-Loneliness-Scale (3 items)
Malnutrition 2 Up to five years Malnutrition is measured by weight
Calf circumference Up to five years Calf circumference is measured in a standardized position and documented in centimeter.
Anaesthesiological Risk 1 At the beginning of the observation Anaesthesiological risk will be described by American Society of Anesthesiologists Classification (ASA Class)
Incidence of postoperative delirium Up to 5 days Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), CAM/CAM-ICU, Nu-DESC and Chart Review.
Living conditions Up to five years Dental health Up to five years The dental status is determined by tooth doctors
Anaesthesiological Risk 3 Participants will be followed up during surgery, an estimated duration of 1 hour Anaesthesiological risk will be measured by type of anaesthesia
Depth of sedation on the Intensive Care Unit Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days Sedation is measured by Richmond Agitation Sedation Scale.
Agitation on the peripheral ward Participants will be followed for the duration of hospital stay, an expected average of 7 days 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.
Severity of postoperative delirium Up to 5 days 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).
Quality of sleep Up to 5 years Quality of sleep is measured by the Insomnia Severity Index.
Organ dysfunctions Up to hospital discharge, an expected average of 7 days Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications
Plausibility check variables Up to 5 years Variables affecting performance of cognitive testings
Revison surgery Up to 5 years Surgery performed to replace or compensate for a failed implant or to correct undesirable sequelae of previous surgery.
Outpatient treatment Up to 5 years Treatment outside of the hospital in an associated facility for diagnosis or treatment.
Pain scale for patients able of pain self-assessment Up to hospital discharge, an expected average of 5 days Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V).
Pain scales for patients unable of pain self-assessment Up to hospital discharge, an expected average of 5 days 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.
Stress level Up to 5 days Stress level is measured by stress thermometer
Generalized anxiety Up to 5 days Anxiety will be measured with the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Depression Up to 5 years Depression is measured by PHQ-8. Scores represent:0-5 = mild, 6-10 = moderate, 11-15 = moderately severe, 16-20 = severe depression
Routine laboratory Up to hospital discharge, an expected average of 7 days Quality of life Up to 5 years Quality of life will be measured with the EQ-5D-5L
Postoperative electroencephalography (EEG) spectral analysis with band power Up to seven days Spectral analysis with band power are measured by EEG at third postoperative day and delirium dependent until postoperative day 7.
Evaluation of pain Up to three months Pain is measured with dolosys paintracker
Subjective/By proxy assessment of cognitive impairment Up to five years Medication Up to 5 years Prescribed regular drug intake from baseline at all follow ups including perioperative application of drugs, infusions and transfusions will be evaluated.
Re-admission Up to 5 years Hospital readmission is an episode when a patient who had been discharged from a hospital is admitted again within a specified time interval.
Motivational incongruence Up to five years The incongruence questionnaire (Der Inkongruenzfragebogen)
Dementia Up to 5 years 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).
Leisure behavior Up to five years Questionnaire on frequency of cognitively stimulating leisure activities
Social support Up to five years Social support is measured with the Berliner Social-Support Skalen BSSS-17
Living situation Up to five years Living situation is measured with te question: How do you live?
Trial Locations
- Locations (3)
Arbeitsbereich Physikalische Medizin
🇩🇪Berlin, Germany
Internistische Hausarztpraxis
🇩🇪Berlin, Germany
Department of Anesthesiology and Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany