Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Not Applicable

Completed

• Conditions: Postoperative Delirium
• Interventions: Other: Delirium assessment; Other: MMSE (Mini Mental State Examination); Other: Barthel index; Other: HADS (Hospital Anxiety and Depression Scale); Other: MNA-SF (Mini Nutritional Assessment - Short Form); Device: NIRS (Near-Infrared Spectroscopy); Other: CIRS (Cumulative Illness Rating Scale)

• Registration Number: NCT02585128
• Lead Sponsor: Cardiocentro Ticino

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2019-05
• Study Completion: 2021-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients following TAVI	MNA-SF (Mini Nutritional Assessment - Short Form)	-
Patients following TAVI	NIRS (Near-Infrared Spectroscopy)	-
Patients following TAVI	Barthel index	-
Patients following TAVI	Delirium assessment	-
Patients following TAVI	HADS (Hospital Anxiety and Depression Scale)	-
Patients following TAVI	MMSE (Mini Mental State Examination)	-
Patients following TAVI	CIRS (Cumulative Illness Rating Scale)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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 functional abilities	Changes from baseline up to 5 day and 3-months	Change of Barthel Index (for Activities of Daily Living, ADL)
Trajectories of neurocognitive function	Changes from baseline up to 5 day and 3-months	Change of Mini-Mental State Examination (MMSE)

Trial Locations

Locations (1)

Cardiocentro Ticino; 🇨🇭 Lugano, Canton Ticino, Switzerland