Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation

Anesthesia Clinical Trial

— DELIRIUMTAVI  

Official title:

Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03323619
• Other study ID #: PSS2017/DELIRIUMTAVI-MATTEI/YB
• Status: Recruiting
• Start date: November 2, 2017
• Est. completion date: November 2, 2020

Study information

• Verified date: September 2018
• Source: Central Hospital, Nancy, France
• Contact: FRITZ Caroline, MD
• Phone: +33383157379
• Email: fritzcaro[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. The postoperative complications are, on the one hand, well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. There is no consensus on best anesthesia technique for TAVI procedure managment. Between teams practices are different. It may consist of general anesthesia (GA) or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve replacement with TAVI procedure

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2, 2020
• Est. primary completion date: August 2, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospital admission for TAVI femoral way

• Age > 18 years

• Psychiatric disease

Exclusion Criteria:

• Opposition of the operator (Interventional Cardiologist or Surgeon) to one of the two anesthesia technique

• Contraindication to local anesthesia with sedation: agitation, delirium, allergy to local anesthetics, risk of inhalation

• Opposition of the patient to use his data for research

Related Conditions & MeSH terms

• Anesthesia
• Aortic Valve Disease
• Delirium
• Post-Op Complication
• Postoperative Complications

Intervention

Procedure:
• anesthesia type
No intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice

Locations

Country	Name	City	State
France	CHRU - Hopital de Brabois	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium	post-operative delirium after TAVI	7 days
Secondary	ICU stay	duration of stay in ICU	30 days