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

Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Sponsors

Lead sponsor: Cardiocentro Ticino

Source Cardiocentro Ticino
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.

Overall Status Unknown status
Start Date September 2015
Completion Date September 2018
Primary Completion Date September 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of delirium Day 1-5 after transcatheter aortic valve implantation
Secondary Outcome
Measure Time Frame
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
Trajectories of functional abilities Changes from baseline up to 5 day and 3-months
Mortality 30-days, 3-months and 1 year
Enrollment 97
Condition
Intervention

Intervention type: Other

Intervention name: Delirium assessment

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)

Arm group label: Patients following TAVI

Intervention type: Other

Intervention name: MMSE (Mini Mental State Examination)

Arm group label: Patients following TAVI

Intervention type: Other

Intervention name: Barthel index

Arm group label: Patients following TAVI

Intervention type: Other

Intervention name: HADS (Hospital Anxiety and Depression Scale)

Arm group label: Patients following TAVI

Intervention type: Other

Intervention name: MNA-SF (Mini Nutritional Assessment - Short Form)

Arm group label: Patients following TAVI

Intervention type: Device

Intervention name: NIRS (Near-Infrared Spectroscopy)

Description: Regional cerebral oxygen saturation monitoring during TAVI procedure

Arm group label: Patients following TAVI

Intervention type: Other

Intervention name: CIRS (Cumulative Illness Rating Scale)

Arm group label: Patients following TAVI

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

Gender: All

Minimum age: 65 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Tiziano Cassina, MD Principal Investigator Cardiocentro Ticino
Overall Contact

Last name: Tiziano Cassina, MD

Phone: +41 (0)91 805 31 83

Email: [email protected]

Location
facility status contact investigator
Cardiocentro Ticino Recruiting Tiziano Cassina, MD +41 (0)91 8053183 [email protected] Sara Clivio, MD Sub-Investigator Michele Villa, RN Sub-Investigator Martino Regazzi, PsyD, PsyaD Sub-Investigator
Location Countries

Switzerland

Verification Date

October 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Cardiocentro Ticino

Investigator full name: Tiziano Cassina

Investigator title: Tiziano Cassina, MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Patients following TAVI

Arm group type: Other

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov