Subarachnoid HemorrhageNIRS_ICGNCT03367975
NIRS Monitoring During Intracranial Interventions
An observational study of Subarachnoid Hemorrhage and Intracranial Arteriovenous Malformation, run by University Hospital, Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Intracranial Arteriovenous Malformation
- What is being tested?
- near infrared spectroscopy
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cerebral aneurysm clipping or av-malformation removal
Who may be able to join
- patients scheduled for aneurysm clipping or av-malformation removal
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn
Bonn, 53105
Martin Soehle, MD, DESA, D habil, ++49-228-287-16512, martin.soehle@ukb.uni-bonn.de
Marcus Thudium, MD
About this study
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.
- Being tested
- near infrared spectroscopy
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near infrared spectroscopyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study startMar 2014
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Soehle, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367975
- Sponsor's protocol ID
- NIRS_039/14
- Acronym
- NIRS_ICG
- Status last verified
- Dec 2017
- First submitted
- 3 Oct 2014
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRS Monitoring During Intracranial Interventions
- ClinicalTrials.gov ID
- NCT03367975
- Acronym / sponsor ID
- NIRS_ICG / NIRS_039/14
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cerebral aneurysm clipping or av-malformation removal
Key inclusion criteria (1 listed)
- patients scheduled for aneurysm clipping or av-malformation removal
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| near infrared spectroscopy | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn
Bonn, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Intracranial Arteriovenous Malformation, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of rSO2 - change [%] induced by ICG-application (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.