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

NCT ID: NCT03323619

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-02

Study Completion Date

2020-11-02

Brief Summary

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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

Detailed Description

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Conditions

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Delirium Post-Op Complication Anesthesia Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GA

No intervention. General anesthesia is decided by the physicien according to his usual practice

anesthesia type

Intervention Type PROCEDURE

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

LASed

No intervention. Local anesthesia with sedation is decided by the physicien according to his usual practice

anesthesia type

Intervention Type PROCEDURE

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

Interventions

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anesthesia type

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MATTEI Mathieu, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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CHRU - Hopital de Brabois

Nancy, Lorraine, France

Site Status RECRUITING

Countries

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France

Central Contacts

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FRITZ Caroline, MD

Role: CONTACT

+33383157379

MATTEI Mathieu, MD

Role: CONTACT

+33383153521

Facility Contacts

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FRITZ Caroline

Role: primary

+33383157379

MATTEI Matthieu

Role: backup

+33383153521

Other Identifiers

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PSS2017/DELIRIUMTAVI-MATTEI/YB

Identifier Type: -

Identifier Source: org_study_id

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