Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Postoperative Delirium Clinical Trial

Official title:

Incidence and Risk Factors of Acute Postoperative Confusion State After Trans-catheter Aortic Valve Implantation (TAVI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585128
• Other study ID #: DELTAVI-CCT-ICU-2015
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: January 2021

Study information

• Verified date: April 2024
• Source: Cardiocentro Ticino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: January 2021
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Other:
• Delirium 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)
• MMSE (Mini Mental State Examination)

• Barthel index

• HADS (Hospital Anxiety and Depression Scale)

• MNA-SF (Mini Nutritional Assessment - Short Form)

Device:
• NIRS (Near-Infrared Spectroscopy)
Regional cerebral oxygen saturation monitoring during TAVI procedure

Other:
• CIRS (Cumulative Illness Rating Scale)

Locations

Country	Name	City	State
Switzerland	Cardiocentro Ticino	Lugano	Canton Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Cardiocentro Ticino

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TAVI complications	Complications according to VARC-2 (Valve Academic Research Consortium -2)	Participants will be followed for the first 72-96 hours after TAVI
Primary	Incidence of delirium	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.	Day 1-5 after transcatheter aortic valve implantation
Secondary	Risk factors for postoperative delirium	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	Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation
Secondary	Onset of delirium		Day 1-5 after transcatheter aortic valve implantation
Secondary	Complications of delirium	Complications delirium related	Day 1-5 after transcatheter aortic valve implantation
Secondary	Type of delirium	Delirium classification according to Delirium Motor Subtype Scale (DMSS-4)	Day 1-5 after transcatheter aortic valve implantation
Secondary	Trajectories of neurocognitive function	Change of Mini-Mental State Examination (MMSE)	Changes from baseline up to 5 day and 3-months
Secondary	Trajectories of functional abilities	Change of Barthel Index (for Activities of Daily Living, ADL)	Changes from baseline up to 5 day and 3-months
Secondary	Mortality	Postoperative survival	30-days, 3-months and 1 year