Postoperative Delirium
Conditions
Keywords
Delirium, Transcatheter Aortic Valve Implantation, Elderly
Brief summary
Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium. Acute neurocognitive dysfunctions are associated with adverse outcomes in these population. The objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after TAVI.
Interventions
OTHERDelirium assessment
During the first post-procedural five days all patients will be evaluated on a daily basis for delirium occurrence by the CAM (Confusion Assessment Method) or CAM - ICU (Confusion Assessment Method - Intensive Care Unit)
OTHERBarthel index
OTHERMNA-SF (Mini Nutritional Assessment - Short Form)
Regional cerebral oxygen saturation monitoring during TAVI procedure
OTHERCIRS (Cumulative Illness Rating Scale)
Sponsors
Cardiocentro Ticino
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65\>years * Patients undergoing transcatheter aortic valve implantation * Patients have given informed consent for participation at the study
Exclusion criteria
* Patient suffering from delirium (CAM diagnosis) at recruitment * Inability to understand the national languages * Emergency procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delirium | Day 1-5 after transcatheter aortic valve implantation | The primary outcome is incidence of delirium. Delirium screening will be carry out using the CAM or CAM-ICU in accordance with local hospital clinical delirium-screening guidelines. The assessment of presence of Delirium will be perform by clinician with CAM in agreement with Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV). CAM is standardized method to enable non-psychiatrically trained clinicians to identify delirium and assesses nine features of delirium: (1) acute onset, (2) inattention, (3) disorganized thinking, (4) altered level of consciousness, (5) disorientation, (6) memory impairment, (7) perceptual disturbances, (8) psychomotor agitation or retardation and (9) altered sleep-wake cycle. Delirium is diagnosed when feature 1 and 2 are present and either 3 or 4 are displayed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors for postoperative delirium | Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation | Association between incidence of delirium and patient vulnerabilities, exposure to noxious or precipitating factors. The risk factors will be divided in pre-procedural, intra-procedural and post-procedural |
| Onset of delirium | Day 1-5 after transcatheter aortic valve implantation | — |
| Complications of delirium | Day 1-5 after transcatheter aortic valve implantation | Complications delirium related |
| Trajectories of neurocognitive function | Changes from baseline up to 5 day and 3-months | Change of Mini-Mental State Examination (MMSE) |
| Trajectories of functional abilities | Changes from baseline up to 5 day and 3-months | Change of Barthel Index (for Activities of Daily Living, ADL) |
| Mortality | 30-days, 3-months and 1 year | Postoperative survival |
| Type of delirium | Day 1-5 after transcatheter aortic valve implantation | Delirium classification according to Delirium Motor Subtype Scale (DMSS-4) |
Other
| Measure | Time frame | Description |
|---|---|---|
| TAVI complications | Participants will be followed for the first 72-96 hours after TAVI | Complications according to VARC-2 (Valve Academic Research Consortium -2) |
Countries
Switzerland
Outcome results
None listed