NIRS Monitoring During Intracranial Interventions | NCT03367975

Studies
NIRS Monitoring During Intracranial Interventions

NCT03367975

Sponsor

University Hospital, Bonn

Status

Unknown status

Last Update Posted

Dec 11, 2017Actual

Enrollment

12Estimated

Phase

Not provided

Conditions

Subarachnoid Hemorrhage
Intracranial Arteriovenous Malformation

Interventions

near infrared spectroscopy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jan 2018Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Oct 3, 2014

First Submission Date that Met QC Criteria

Dec 4, 2017

First Posted Date

Dec 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2017

Last Update Posted Date

Dec 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Name	Type	Description	Arm Group Labels	Other Names
near infrared spectroscopy	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for aneurysm clipping or av-malformation removal

Exclusion Criteria:

pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing cerebral aneurysm clipping or av-malformation removal

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn	Recruiting	Bonn		53105	Germany

Condition Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage
D002538	Intracranial Arteriovenous Malformations

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019265	Spectroscopy, Near-Infrared

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013057	Spectrum Analysis

Browse Leaves

Not provided

Browse Branches

Not provided