Near INfrared Spectroscopy in Aortic valvE ReplacemenT

NCT ID: NCT01251328

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-04-30

Brief Summary

Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods.

This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the "rapid pacing"-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation; Eligibility for Both Anaesthetic Methods

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

General anaesthesia

General anaesthesia is performed under standardized conditions

Group Type: ACTIVE_COMPARATOR

General anaesthesia

Intervention Type: PROCEDURE

general anaesthesia is performed according to the hospitals standard

Sedation

Sedation is performed under standardized conditions

Group Type: ACTIVE_COMPARATOR

Sedation

Intervention Type: PROCEDURE

Sedation is performed according to the hospitals standard

Interventions

General anaesthesia

general anaesthesia is performed according to the hospitals standard

Intervention Type: PROCEDURE

Sedation

Sedation is performed according to the hospitals standard

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• informed consent
• transcatheter aortic valve implantation

Exclusion Criteria

• denial by patient
• denial by screening anaesthesist
• active neurodegenerative disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

N Patrick Mayr

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick N Mayr, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München

Locations

Deutsches Herzzentrum München

Munich, Bavaria, Germany

Countries

Germany

References

Mayr NP, Hapfelmeier A, Martin K, Kurz A, van der Starre P, Babik B, Mazzitelli D, Lange R, Wiesner G, Tassani-Prell P. Comparison of sedation and general anaesthesia for transcatheter aortic valve implantation on cerebral oxygen saturation and neurocognitive outcomedagger. Br J Anaesth. 2016 Jan;116(1):90-9. doi: 10.1093/bja/aev294. Epub 2015 Sep 29.

Reference Type: DERIVED

PMID: 26424178 (View on PubMed)

Other Identifiers

GE DHM-AN-OR-2010/01

Identifier Type: -

Identifier Source: org_study_id