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Near INfrared Spectroscopy in Aortic valvE ReplacemenT (INSERT)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
General anaesthesia
Sedation
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • informed consent
  • transcatheter aortic valve implantation

Exclusion Criteria:

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

Sites / Locations

  • Deutsches Herzzentrum München

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

General anaesthesia

Sedation

Arm Description

General anaesthesia is performed under standardized conditions

Sedation is performed under standardized conditions

Outcomes

Primary Outcome Measures

Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural
Biomarkers for cerebral ischemia will be measured up to 48 hours

Secondary Outcome Measures

Full Information

First Posted
November 29, 2010
Last Updated
February 9, 2015
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT01251328
Brief Title
Near INfrared Spectroscopy in Aortic valvE ReplacemenT
Acronym
INSERT
Official Title
Near Infrared Spectroscopy in Aortic Valve Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Eligibility for Both Anaesthetic Methods

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General anaesthesia
Arm Type
Active Comparator
Arm Description
General anaesthesia is performed under standardized conditions
Arm Title
Sedation
Arm Type
Active Comparator
Arm Description
Sedation is performed under standardized conditions
Intervention Type
Procedure
Intervention Name(s)
General anaesthesia
Intervention Description
general anaesthesia is performed according to the hospitals standard
Intervention Type
Procedure
Intervention Name(s)
Sedation
Intervention Description
Sedation is performed according to the hospitals standard
Primary Outcome Measure Information:
Title
Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural
Description
Biomarkers for cerebral ischemia will be measured up to 48 hours
Time Frame
up to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: informed consent transcatheter aortic valve implantation Exclusion Criteria: denial by patient denial by screening anaesthesist active neurodegenerative disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick N Mayr, MD
Organizational Affiliation
Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
D-80636
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26424178
Citation
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.
Results Reference
derived

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Near INfrared Spectroscopy in Aortic valvE ReplacemenT

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