Skip to main content
OpenTrials
Completed

NCT Number: NCT03540433

International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arbeitsbereich Physikalische Medizin, Berlin, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
  • Aged ≥ 70 years
  • Informed consent

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative cognitive dysfunction (POCD)

    Time frame: Up to 1 year

    Neuropsychological testing

Secondary outcomes

  1. Incidence of postoperative cognitive dysfunction (POCD)

    Time frame: Up to 5 years

    Neuropsychological testing

  2. Positive cognitive screening

    Time frame: Up to 5 years

    Short neuropsychological testing

  3. Mild Neurocognitive Disorder

    Time frame: 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

  4. Major Neurocognitive Disorder

    Time frame: 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

  5. Cerobrospinal fluid biomarker for diagnosing dementia

    Time frame: 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)).

  6. Blood biomarker for diagnosing dementia

    Time frame: Up to five years

    Patients consented on blood sampling receive biomarker analysis from blood (Apolipoprotein E).

  7. Findings of memory consultation session

    Time frame: Up to five years

  8. Comorbidities

    Time frame: Up to five years

    Comorbidities will be quantified by use of Charlson Comorbidity index

  9. Nutritional status

    Time frame: Up to five years

    Changes in the nutritional status after elective surgery are measured by a questionnaire.

  10. Malnutrition 1

    Time frame: Up to five years

    Malnutrition is measured by the Body mass index

  11. Malnutrition 2

    Time frame: Up to five years

    Malnutrition is measured by weight

  12. Malnutrition 3

    Time frame: Up to five years

    Malnutrition is measured by weight

  13. Dental health

    Time frame: Up to five years

    The dental status is determined by tooth doctors

  14. Sarcopenia

    Time frame: 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.

  15. Calf circumference

    Time frame: Up to five years

    Calf circumference is measured in a standardized position and documented in centimeter.

  16. Arm circumference

    Time frame: Up to five years

    Arm circumference is measured in a standardized position and documented in centimeter.

  17. Adherence to Mediterranean diet (MD)

    Time frame: 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.

  18. Nutrition in the hospital

    Time frame: Up to five years

    Participants will be followed for the duration of hospital stay, an expected average of 7 days

  19. Physical activity

    Time frame: At the beginning of the observation

    Physical activity is evaluated by interviewing the Patient.

  20. Surgical risk

    Time frame: 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.

  21. Anaesthesiological Risk 1

    Time frame: At the beginning of the observation

    Anaesthesiological risk will be described by American Society of Anesthesiologists Classification (ASA Class)

  22. Anaesthesiological Risk 2

    Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour

    Anaesthesiological risk will be measured by length of anesthesia

  23. Anaesthesiological Risk 3

    Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour

    Anaesthesiological risk will be measured by type of anaesthesia

  24. Intraoperative depth of anaesthesia

    Time frame: 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.

  25. Depth of sedation on the Intensive Care Unit

    Time frame: 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.

  26. Sedation on the peripheral ward

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    Sedation is measured by Richmond Agitation Sedation Scale.

  27. Agitation on the peripheral ward

    Time frame: 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.

  28. Incidence of postoperative delirium

    Time frame: 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.

  29. Severity of postoperative delirium

    Time frame: 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).

  30. Duration of Delirium

    Time frame: 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

  31. Pain scale for patients able of pain self-assessment

    Time frame: Up to hospital discharge, an expected average of 5 days

    Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V).

  32. Pain scales for patients unable of pain self-assessment

    Time frame: 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.

  33. Intensive care unit length of stay

    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 stay describes every day spent in an ICU bed.

  34. Hospital length of stay

    Time frame: 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.

  35. Perioperative Anxiety

    Time frame: Up to 5 days

    Perioperative anxiety will be measured with APAIS preoperatively and the Faces Anxiety Scale (FAS) and during hospital stay.

  36. Perception of stress

    Time frame: Up to 5 days

    Stress is measured by Perceived Stress Questionnaire 20

  37. Stress level

    Time frame: Up to 5 days

    Stress level is measured by stress thermometer

  38. Generalized anxiety

    Time frame: Up to 5 days

    Anxiety will be measured with the Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  39. Depression

    Time frame: 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

  40. Quality of sleep

    Time frame: Up to 5 years

    Quality of sleep is measured by the Insomnia Severity Index.

  41. Routine laboratory

    Time frame: Up to hospital discharge, an expected average of 7 days

  42. Organ dysfunctions

    Time frame: Up to hospital discharge, an expected average of 7 days

    Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications

  43. Subjective/By proxy assessment of cognitive impairment

    Time frame: Up to five years

  44. Medication

    Time frame: 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.

  45. Quality of life

    Time frame: Up to 5 years

    Quality of life will be measured with the EQ-5D-5L

  46. Level of dependency

    Time frame: 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).

  47. Plausibility check variables

    Time frame: Up to 5 years

    Variables affecting performance of cognitive testings

  48. Re-admission

    Time frame: 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.

  49. Revison surgery

    Time frame: Up to 5 years

    Surgery performed to replace or compensate for a failed implant or to correct undesirable sequelae of previous surgery.

  50. Outpatient treatment

    Time frame: Up to 5 years

    Treatment outside of the hospital in an associated facility for diagnosis or treatment.

  51. Mortality

    Time frame: Up to 5 years

    The number of deaths in a given period.

  52. Dementia

    Time frame: 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).

  53. Motivational incongruence

    Time frame: Up to five years

    The incongruence questionnaire (Der Inkongruenzfragebogen)

  54. Leisure behavior

    Time frame: Up to five years

    Questionnaire on frequency of cognitively stimulating leisure activities

  55. Demographic variables

    Time frame: Up to five years

  56. Living conditions

    Time frame: Up to five years

  57. Postoperative electroencephalography (EEG) spectral analysis with band power

    Time frame: Up to seven days

    Spectral analysis with band power are measured by EEG at third postoperative day and delirium dependent until postoperative day 7.

  58. Evaluation of pain

    Time frame: Up to three months

    Pain is measured with dolosys paintracker

  59. Loneliness

    Time frame: Up to five years

    Loneliness is measured with the UCLA-Loneliness-Scale (3 items)

  60. Social support

    Time frame: Up to five years

    Social support is measured with the Berliner Social-Support Skalen BSSS-17

  61. Living situation

    Time frame: Up to five years

    Living situation is measured with te question: How do you live?

Other outcomes

  1. Obesity 1

    Time frame: At the beginning of the observation

    Obesity is measured by body mass index (BMI)

  2. Obesity 2

    Time frame: At the beginning of the observation

    Obesity is measured by waist to hip ratio

  3. Variables of adjusting

    Time frame: At the beginning of the observation

    Reading / writing weakness, hendedness, native speaker

  4. Frailty

    Time frame: At the beginning of the observation

    Frailty will be measured by Fried's criteria (Physical Frailty Phenotype), Fried et al: Frailty in older adults: evidence for a phenotype. J.Gerontol.A Biol.Sci.Med.Sci. 2001; 56: M146-M156 and evaluated in a short comprehensive geriatric assessment as decribed by Birkelbach, O. et al. Warum und wie sollte ich Frailty erfassen? - ein Ansatz für die Anästhesieambulanz. Anasthesiol. Intensivmed. Notfallmedizin Schmerztherapie 52, 765-776 (2017).

  5. Cognitive Reserve

    Time frame: At the beginning of the observation

    Level of education (years of formal training, last occupation, ISCED-2011 and crystalline intelligence [IQ-variable calculated with NART/MWT-A or other national equivalent ] will be used to evaluate cognitive reserve.

  6. Crystalline Intelligence

    Time frame: At the beginning of the observation

    Mehrfachwahl-Wortschatz-Intelligenztest (MWT-A) and National Adult Reading Test (NART)

  7. Previous professional activity

    Time frame: At the beginning of the observation

    Interview guide employment situation and previous professional activity adapted to Engstler (2017); Classification according to ISCO 08; Workload indices according to Kroll (2011)

  8. Delusion proneness

    Time frame: At the beginning of the observation

    Delusion proneness is measured by Peter's Delusion Inventory

  9. Physical activity

    Time frame: At the beginning of the observation

    History of physical activity less than 30 minutes / day (i.e. moderate increase in heart rate due to fast walking, cycling or other exercise)

  10. Pre-operative electroencephalography (EEG) spectral analysis with band power

    Time frame: At the beginning of the observation

    Spectral analysis with band power are measured by EEG

  11. Preoperative Cognitive Impairment (PreCI)

    Time frame: At the beginning of the observation

    Preoperative Cognitive Impairment (PreCI) is measured by computerized and paper pencil tests

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Evaluation of POCD-Census Prospective, International Observation Study

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 30, 2018
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.