Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Cardiocentro Ticino

Status: Completed

Conditions: Postoperative Delirium

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02585128

DELTAVI-CCT-ICU-2015

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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201 participants in 1 patient group

Patients following TAVI

Other group

Treatment:

Other: Delirium assessment

Other: HADS (Hospital Anxiety and Depression Scale)

Device: NIRS (Near-Infrared Spectroscopy)

Other: Barthel index

Other: CIRS (Cumulative Illness Rating Scale)

Other: MMSE (Mini Mental State Examination)

Other: MNA-SF (Mini Nutritional Assessment - Short Form)