Skip to main content
OpenTrials
Completed

NCT Number: NCT02585128

Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delirium assessment

Other

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)

Other

Barthel index

Other

HADS (Hospital Anxiety and Depression Scale)

Other

MNA-SF (Mini Nutritional Assessment - Short Form)

Other

NIRS (Near-Infrared Spectroscopy)

Device

Regional cerebral oxygen saturation monitoring during TAVI procedure

CIRS (Cumulative Illness Rating Scale)

Other

Primary outcomes

  1. Incidence of delirium

    Time frame: 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 outcomes

  1. Risk factors for postoperative delirium

    Time frame: 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

  2. Onset of delirium

    Time frame: Day 1-5 after transcatheter aortic valve implantation

  3. Complications of delirium

    Time frame: Day 1-5 after transcatheter aortic valve implantation

    Complications delirium related

  4. Type of delirium

    Time frame: Day 1-5 after transcatheter aortic valve implantation

    Delirium classification according to Delirium Motor Subtype Scale (DMSS-4)

  5. Trajectories of neurocognitive function

    Time frame: Changes from baseline up to 5 day and 3-months

    Change of Mini-Mental State Examination (MMSE)

  6. Trajectories of functional abilities

    Time frame: Changes from baseline up to 5 day and 3-months

    Change of Barthel Index (for Activities of Daily Living, ADL)

  7. Mortality

    Time frame: 30-days, 3-months and 1 year

    Postoperative survival

Other outcomes

  1. TAVI complications

    Time frame: Participants will be followed for the first 72-96 hours after TAVI

    Complications according to VARC-2 (Valve Academic Research Consortium -2)

Sponsors and collaborators

Lead sponsor

Cardiocentro Ticino

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Oct 23, 2015
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.