Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

NCT02585128 | Completed

• 1 other identifier: DELTAVI-CCT-ICU-2015
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Keywords

Delirium; Transcatheter Aortic Valve Implantation; Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Risk factors for postoperative delirium

  Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation

• Onset of delirium

  Day 1-5 after transcatheter aortic valve implantation

• Complications of delirium

  Day 1-5 after transcatheter aortic valve implantation

• Type of delirium

  Day 1-5 after transcatheter aortic valve implantation

• Trajectories of neurocognitive function

  Changes from baseline up to 5 day and 3-months

Other Outcomes (1)

• TAVI complications

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

Study Arms (1)

Patients following TAVI

OTHER

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)

Interventions

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)

Patients following TAVI

MMSE (Mini Mental State Examination) OTHER

Patients following TAVI

Barthel index OTHER

Patients following TAVI

HADS (Hospital Anxiety and Depression Scale) OTHER

Patients following TAVI

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

Patients following TAVI

NIRS (Near-Infrared Spectroscopy) DEVICE

Regional cerebral oxygen saturation monitoring during TAVI procedure

Patients following TAVI

CIRS (Cumulative Illness Rating Scale) OTHER

Patients following TAVI

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65\>years
• Patients undergoing transcatheter aortic valve implantation
• Patients have given informed consent for participation at the study

You may not qualify if:

• Patient suffering from delirium (CAM diagnosis) at recruitment
• Inability to understand the national languages
• Emergency procedures

Sponsors & Collaborators

• Cardiocentro Ticino: lead

Study Sites (1)

Cardiocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

Location

MeSH Terms

Conditions

Emergence Delirium; Delirium

Interventions

Mental Status and Dementia Tests; 4-amino-4'-hydroxylaminodiphenylsulfone; Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Tiziano Cassina, MD

  Cardiocentro Ticino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tiziano Cassina, MD

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 23, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: January 1, 2021
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CH (1)