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INVESTIGATE THE ASSOCIATION BETWEEN VIRAL NEUROTOXIC INFECTION AND POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE

Studies

Study First Submitted Date 2023-03-28
Study First Posted Date 2023-04-10
Last Update Posted Date 2023-04-10
Start Month Year March 1, 2024
Primary Completion Month Year December 1, 2026
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-04-10

Conditions

Sequence: 51742451
Name POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE
Downcase Name postoperative delirium and postoperative cognitive decline

Id Information

Sequence: 39817053
Id Source org_study_id
Id Value CONNECTED-ObsCT

Interventions

Sequence: 52064130
Intervention Type Diagnostic Test
Name Virological screening
Description The preoperative viral screening protocol will start with a self-assessment questionnaire that will be provided to all the enrolled patients, where they will be asked to indicate previously SARS-CoV-2, HPV, EBV, CMV infections. Collection of peripheral blood mononuclear cells (PBMCs) from blood samples and serum specimens for the virological screening (HPV, EBV, CMV, SARS-CoV-2). Preoperative MoCA assessment, follow-up 5 days, 3 months and 6 months after the surgery.

Design Outcomes

Sequence: 175989616 Sequence: 175989612 Sequence: 175989613 Sequence: 175989614 Sequence: 175989615
Outcome Type secondary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure training of healthcare practitioners Measure ASSOCIATION BETWEEN VIRAL NEUROTOXIC INFECTION AND POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE Measure Association between POCD/DNC and HSV/CMV/EBV Measure POCD risk calculator Measure perioperative safety management
Time Frame 24 months Time Frame 24 months Time Frame 24 months Time Frame 24 months Time Frame 24 months
Description Delivery of training to healthcare practitioners concerning the preoperative evaluation of POD risk and the identification of patients at risk. Description to evaluate if patients undergoing general anaesthesia for elective major surgeries lasting longer than 1 hour that have an history of COVID-19 (not an active SARS-CoV-2 infection) do have a higher risk to develop postoperative cognitive dysfunction (POCD)/delayed neurocognitive recovery (DNC) at 3 months and 6 months follow-up after surgery. Description Association between POCD/DNC with preoperative exposure to other neurotropic viruses: Herpes simplex virus (HS), Cytomegalovirus (CMV), and Epstein Barr virus (EBV). Description Development -on the basis of collected data- of a software dedicated to calculating in the preoperative phase the risk for early postoperative delirium or POCD/PNDs Description Development of a conceptual model of "perioperative safety management": as in civil aviation traffic control, increasing the patients' perception of healthcare safety and quality.

Browse Conditions

Sequence: 191761020 Sequence: 191761021 Sequence: 191761022 Sequence: 191761023 Sequence: 191761024 Sequence: 191761025 Sequence: 191761026 Sequence: 191761027 Sequence: 191761028 Sequence: 191761029 Sequence: 191761030 Sequence: 191761031
Mesh Term Delirium Mesh Term Emergence Delirium Mesh Term Cognitive Dysfunction Mesh Term Confusion Mesh Term Neurobehavioral Manifestations Mesh Term Neurologic Manifestations Mesh Term Nervous System Diseases Mesh Term Neurocognitive Disorders Mesh Term Mental Disorders Mesh Term Cognition Disorders Mesh Term Postoperative Complications Mesh Term Pathologic Processes
Downcase Mesh Term delirium Downcase Mesh Term emergence delirium Downcase Mesh Term cognitive dysfunction Downcase Mesh Term confusion Downcase Mesh Term neurobehavioral manifestations Downcase Mesh Term neurologic manifestations Downcase Mesh Term nervous system diseases Downcase Mesh Term neurocognitive disorders Downcase Mesh Term mental disorders Downcase Mesh Term cognition disorders Downcase Mesh Term postoperative complications Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47920917
Agency Class OTHER
Lead Or Collaborator lead
Name University of Roma La Sapienza

Central Contacts

Sequence: 11922066 Sequence: 11922067
Contact Type primary Contact Type backup
Name Federico Bilotta Name Susanna Fontana
Phone +393393370822 Phone +393384230128
Email federico.bilotta@uniroma1.it Email s.fontana@formit.org
Role Contact Role Contact

Eligibilities

Sequence: 30515234
Sampling Method Probability Sample
Gender All
Minimum Age 65 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Population candidates aged ≥ 65 years underging major elective surgery under general anaesthesia
Criteria The recruitment's inclusion criteria will select patients: Aged ≥ 65 years Undergoing elective surgical procedures, scheduled to last longer than one hour. Under general anaesthesia, including the procedures using mechanical ventilation, total intravenous anaesthesia (TIVA) or balanced anaesthesia. Planned inpatient length of stay in the hospital ≥ 2 days With and without preoperative exposure to the following neurotoxic viruses: SARS-CoV-2 (COVID-19), Herpes simplex virus (HS), Cytomegalovirus (CMV), and Epstein Barr virus (EBV). Exclusion Criteria: Patients aged less than 65 years old. Undergoing non elective surgical procedures. Undergoing surgical procedures lasting less than one hour. Undergoing surgical procedures entailing the impairment of the verbal production, such as brain surgery, maxillofacial surgery and otorhinolaryngology operations. The surgical procedures excluded are the ones affecting the speech and cognitive functions and the surgeries with specific risks of postoperative cognitive impairment (such as cardiac surgery and carotid surgery). Undergoing surgical procedures implying local anaesthesia. Undergoing surgical procedures that do not imply the insertion of an airway device (such as endotracheal tube or laryngeal mask) or the protracted mechanical ventilation. Undergoing surgery procedures with planned mechanical ventilation after surgery / re-intubation. Patients with language barriers. Patients under legal guardianship and with pre-existing cognitive dysfunction (MoCA < 21 points). Patients not giving the informed consent.
Adult False
Child False
Older Adult True

Calculated Values

Sequence: 254066225
Registered In Calendar Year 2023
Were Results Reported False
Has Single Facility False
Minimum Age Num 65
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30264267
Observational Model Case-Control
Time Perspective Prospective

Intervention Other Names

Sequence: 26464736
Intervention Id 52064130
Name cognitive assessment

Responsible Parties

Sequence: 28644548
Responsible Party Type Principal Investigator
Name Federico Bilotta
Title Professor
Affiliation University of Roma La Sapienza