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| ID | Type | Description | Link |
|---|---|---|---|
| 302168 | Other Identifier | Integrated Research Application System | |
| Protocol version 13/06/2022 | Other Identifier | University of Oxford |
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| Name | Class |
|---|---|
| Oxford University Hospitals NHS Trust | OTHER |
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Loss of cognitive function after major surgery is a significant risk in older people. It can occur acutely in the days after surgery as delirium or in months to years later as a persistent reduction in brain function termed neurocognitive decline. Together these conditions are called post operative cognitive dysfunction (POCD). They can be acutely distressing for patients and are associated with other problems after surgery.
The causes of post operative cognitive dysfunction are poorly understood. Studies have been limited by a lack of biomarkers to predict which patients are at high risk of developing POCD. Research suggests silent strokes occurring during surgery and different sensitivities to anaesthetic medicines are associated with POCD.
The project consists of a feasibility study to investigate markers that might predict people over 65 years old getting POCD. The first biomarker is a non-invasive monitor of anaesthetics effects on brain function called electroencephalography (EEG): The investigators will identify which EEG patterns predict delirium within five days surgery. The second set of biomarkers are two blood tests of proteins that increase after strokes: these are neurofilament light chains and tau proteins. The investigators will establish if these can be used to predict having POCD up to one year after surgery and long term cognitive impairment up to 5 years after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biomarker monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative electroencephalography recording | Procedure | Intraoperative electroencephalography measurements, a non-invasive routine monitoring device used during anaesthesia to measure the brain's electrical activity |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility to conduct the study | The total number of participants who are successfully recruited, receive the study procedures and complete both 90 day and 1 year follow up after surgery. | 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delirium incidence and severity | Postoperative delirium identified as being present according to a positive result using 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) and severity according to the absolute value on the 3D-CAM-Severity which is a scale converting the 3-Minute Diagnostic Interview for Confusion Assessment Method into a scale from 0-7. Higher scores are associated with worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults over 65 years of age having major elective surgery under general anaesthesia
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| Name | Affiliation | Role |
|---|---|---|
| Martyn Ezra | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Berkshire NHS Foundation Trust | Reading | Berkshire | RG1 5AN | United Kingdom |
Participants will be asked for consent to share anonymized data with other researchers.
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Blood tests will be disposed of after analysis according to standard laboratory operating procedures
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| Neurofilament light chain measurement | Procedure | Measurement of the level of neurofilament light chain in a blood sample |
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| Tau protein measurement | Procedure | Measurement of the level of tau protein in a blood sample |
|
| Up to 5 days after surgery |
| Days alive and at home up to 90 days after surgery | The number of days a participant is alive and how many are spent at home after surgery | 90 days after surgery |
| Change in neurofilament light chains and tau proteins levels pre- to post operatively | Measurements of the level of the biomarkers neurofilament light chain and tau protein in plasma | Up to 2 days after surgery |
| Postoperative neurocognitive dysfunction and severity | Cognitive impairment measured on Montreal Objective Cognitive Assessment administered by telephone. The scale is 0-22 with higher scores representing better outcome. | Up to 1 year after surgery |
| Long term cognitive impairment | Incidence of new diagnosis in primary or secondary care of dementia or mild cognitive impairment | Up to 5 years after surgery |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D000079690 | Postoperative Cognitive Complications |
| D060825 | Cognitive Dysfunction |
| C537987 | Charcot-Marie-Tooth disease, Type 1F |
| D057180 | Frontotemporal Dementia |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D003072 | Cognition Disorders |
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D057177 | TDP-43 Proteinopathies |
| D019636 | Neurodegenerative Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016875 | tau Proteins |
| ID | Term |
|---|---|
| D008869 | Microtubule-Associated Proteins |
| D008868 | Microtubule Proteins |
| D003598 | Cytoskeletal Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
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