NCT02585128

Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Cardiocentro Ticino · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-05-01
• Completion: 2021-01-01
• First posted: 2015-10-23
• Last updated: 2024-04-18

Locations

1 site across 1 country: Switzerland