NIRS Monitoring During Intracranial Interventions

Subarachnoid Hemorrhage Clinical Trial

— NIRS_ICG  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03367975
• Other study ID #: NIRS_039/14
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2014
• Last updated: December 4, 2017
• Start date: March 2014
• Est. completion date: March 2018

Study information

• Verified date: December 2017
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled for aneurysm clipping or av-malformation removal

Exclusion Criteria:

• pregnancy

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Hemorrhage
• Intracranial Arteriovenous Malformation
• Intracranial Arteriovenous Malformations
• Subarachnoid Hemorrhage

Intervention

Other:
• near infrared spectroscopy

Locations

Country	Name	City	State
Germany	Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of rSO2 - change [%] induced by ICG-application	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	1 hour