Near INfrared Spectroscopy in Aortic valvE ReplacemenT
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Near Infrared Spectroscopy in Aortic Valve Replacement
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2010
CompletedFirst Posted
Study publicly available on registry
December 1, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFebruary 10, 2015
February 1, 2015
1.3 years
November 29, 2010
February 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural
Biomarkers for cerebral ischemia will be measured up to 48 hours
up to 48 hours
Study Arms (2)
General anaesthesia
ACTIVE COMPARATORGeneral anaesthesia is performed under standardized conditions
Sedation
ACTIVE COMPARATORSedation is performed under standardized conditions
Interventions
general anaesthesia is performed according to the hospitals standard
Eligibility Criteria
You may qualify if:
- informed consent
- transcatheter aortic valve implantation
You may not qualify if:
- denial by patient
- denial by screening anaesthesist
- active neurodegenerative disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deutsches Herzzentrum München
Munich, Bavaria, D-80636, Germany
Related Publications (1)
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.
PMID: 26424178DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick N Mayr, MD
Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 29, 2010
First Posted
December 1, 2010
Study Start
December 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
February 10, 2015
Record last verified: 2015-02