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NIRS Monitoring During Intracranial Interventions (NIRS_ICG)

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ClinicalTrials.gov Identifier: NCT03367975
Recruitment Status : Unknown
Verified December 2017 by Martin Soehle, University Hospital, Bonn.
Recruitment status was:  Recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Martin Soehle, University Hospital, Bonn

Study Description
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Brief Summary:

Near infrared spectroscopy is a valuable tool to monitor cerebral oxygenation during intracranial interventions. However, it yields artificial results when the dye indocyanine green (ICG) is applied, which is routinely done for intraoperative angiography.

The investigators examine, to what extent and which duration NIRS is disturbed following ICG application.


Condition or disease Intervention/treatment
Subarachnoid Hemorrhage Intracranial Arteriovenous Malformation Other: near infrared spectroscopy

Study Design
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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. amount of rSO2 - change [%] induced by ICG-application [ Time Frame: 1 hour ]
    Cerebral oxygenation (rSO2) may be quantified using NIRS. The dye ICG, that is used intraoperatively, affects NIRS, since it changes rSO2 without modifying cerebral oxygenation. The amount, by which rSO2 is altered will be assessed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cerebral aneurysm clipping or av-malformation removal
Criteria

Inclusion Criteria:

  • patients scheduled for aneurysm clipping or av-malformation removal

Exclusion Criteria:

  • pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367975


Locations
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Germany
Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn Recruiting
Bonn, Germany, 53105
Contact: Martin Soehle, MD, DESA, D habil    ++49-228-287-16512    martin.soehle@ukb.uni-bonn.de   
Sub-Investigator: Marcus Thudium, MD         
Sponsors and Collaborators
University Hospital, Bonn
More Information
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Responsible Party: Martin Soehle, Consultant, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT03367975    
Other Study ID Numbers: NIRS_039/14
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases