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Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

NCT02585128 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

  • Postoperative Delirium

Interventions

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)

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)

Regional cerebral oxygen saturation monitoring during TAVI procedure

OTHER

CIRS (Cumulative Illness Rating Scale)

Sponsors & Collaborators

  • Cardiocentro Ticino

    lead OTHER

Principal Investigators

  • Tiziano Cassina, MD · Cardiocentro Ticino

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-05-31
Completion
2021-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02585128 on ClinicalTrials.gov