NCT03367975

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

3.8 years

First QC Date

October 3, 2014

Last Update Submit

December 4, 2017

Conditions

Subarachnoid HemorrhageIntracranial Arteriovenous Malformation

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

near infrared spectroscopyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cerebral aneurysm clipping or av-malformation removal

You may qualify if:

  • patients scheduled for aneurysm clipping or av-malformation removal

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn

Bonn, 53105, Germany

RECRUITING

MeSH Terms

Conditions

Subarachnoid HemorrhageIntracranial Arteriovenous Malformations

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System Vascular MalformationsNervous System MalformationsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesIntracranial Arterial DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

October 3, 2014

First Posted

December 11, 2017

Study Start

March 1, 2014

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

December 11, 2017

Record last verified: 2017-12

Locations

DE(1)