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Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Primary Purpose

Postoperative Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Delirium assessment
MMSE (Mini Mental State Examination)
Barthel index
HADS (Hospital Anxiety and Depression Scale)
MNA-SF (Mini Nutritional Assessment - Short Form)
NIRS (Near-Infrared Spectroscopy)
CIRS (Cumulative Illness Rating Scale)
Sponsored by
Cardiocentro Ticino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Delirium focused on measuring Delirium, Transcatheter Aortic Valve Implantation, Elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cardiocentro TicinoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients following TAVI

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Risk factors for postoperative delirium
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
Complications of delirium
Complications delirium related
Type of delirium
Delirium classification according to Delirium Motor Subtype Scale (DMSS-4)
Trajectories of neurocognitive function
Change of Mini-Mental State Examination (MMSE)
Trajectories of functional abilities
Change of Barthel Index (for Activities of Daily Living, ADL)
Mortality
Postoperative survival

Full Information

First Posted
October 1, 2015
Last Updated
October 22, 2015
Sponsor
Cardiocentro Ticino
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1. Study Identification

Unique Protocol Identification Number
NCT02585128
Brief Title
Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation
Official Title
Incidence and Risk Factors of Acute Postoperative Confusion State After Trans-catheter Aortic Valve Implantation (TAVI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiocentro Ticino

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
Delirium, Transcatheter Aortic Valve Implantation, Elderly

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients following TAVI
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Delirium assessment
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
MMSE (Mini Mental State Examination)
Intervention Type
Other
Intervention Name(s)
Barthel index
Intervention Type
Other
Intervention Name(s)
HADS (Hospital Anxiety and Depression Scale)
Intervention Type
Other
Intervention Name(s)
MNA-SF (Mini Nutritional Assessment - Short Form)
Intervention Type
Device
Intervention Name(s)
NIRS (Near-Infrared Spectroscopy)
Intervention Description
Regional cerebral oxygen saturation monitoring during TAVI procedure
Intervention Type
Other
Intervention Name(s)
CIRS (Cumulative Illness Rating Scale)
Primary Outcome Measure Information:
Title
Incidence of delirium
Description
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.
Time Frame
Day 1-5 after transcatheter aortic valve implantation
Secondary Outcome Measure Information:
Title
Risk factors for postoperative delirium
Description
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
Time Frame
Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation
Title
Onset of delirium
Time Frame
Day 1-5 after transcatheter aortic valve implantation
Title
Complications of delirium
Description
Complications delirium related
Time Frame
Day 1-5 after transcatheter aortic valve implantation
Title
Type of delirium
Description
Delirium classification according to Delirium Motor Subtype Scale (DMSS-4)
Time Frame
Day 1-5 after transcatheter aortic valve implantation
Title
Trajectories of neurocognitive function
Description
Change of Mini-Mental State Examination (MMSE)
Time Frame
Changes from baseline up to 5 day and 3-months
Title
Trajectories of functional abilities
Description
Change of Barthel Index (for Activities of Daily Living, ADL)
Time Frame
Changes from baseline up to 5 day and 3-months
Title
Mortality
Description
Postoperative survival
Time Frame
30-days, 3-months and 1 year
Other Pre-specified Outcome Measures:
Title
TAVI complications
Description
Complications according to VARC-2 (Valve Academic Research Consortium -2)
Time Frame
Participants will be followed for the first 72-96 hours after TAVI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiziano Cassina, MD
Phone
+41 (0)91 805 31 83
Email
tiziano.cassina@cardiocentro.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiziano Cassina, MD
Organizational Affiliation
Cardiocentro Ticino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiocentro Ticino
City
Lugano
State/Province
Canton Ticino
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiziano Cassina, MD
Phone
+41 (0)91 8053183
Email
tiziano.cassina@cardiocentro.org
First Name & Middle Initial & Last Name & Degree
Sara Clivio, MD
First Name & Middle Initial & Last Name & Degree
Michele Villa, RN
First Name & Middle Initial & Last Name & Degree
Martino Regazzi, PsyD, PsyaD

12. IPD Sharing Statement

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Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

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