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

NCT03323619 | Unknown

• 1 other identifier: PSS2017/DELIRIUMTAVI-MATTEI/YB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Delirium; Post-Op Complication; Anesthesia; Aortic Valve Disease

Keywords

Transcatheter aortic valve replacement; Anesthesia technique; Delirium

Outcome Measures

Primary Outcomes (1)

• Delirium

  post-operative delirium after TAVI

  7 days

Secondary Outcomes (1)

• ICU stay

  30 days

Study Arms (2)

GA

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

Procedure: anesthesia type

LASed

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

Procedure: anesthesia type

Interventions

anesthesia type PROCEDURE

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

GA; LASed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient admitted for TAVI intervention

You may qualify if:

• Hospital admission for TAVI femoral way
• Age \> 18 years
• Psychiatric disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU - Hopital de Brabois

Nancy, Lorraine, 54000, France

RECRUITING

MeSH Terms

Conditions

Delirium; Postoperative Complications; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• MATTEI Mathieu, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FRITZ Caroline, MD

CONTACT

+33383157379; fritzcaro@gmail.com

MATTEI Mathieu, MD

CONTACT

+33383153521; m.mattei@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: November 2, 2017
• Primary Completion: August 2, 2020
• Study Completion: November 2, 2020
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

FR (1)