Arterio-venous FistulaNCT03044496
NIRS Measurement After SCP Block
An observational study of Arterio-venous Fistula, run by Marienhospital Stuttgart at 1 site in Germany.
Trial summary
Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes causing increased arterial blood flow and venodilatation . Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing oxygen saturation by detecting the absorption and reflection of near-infrared… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterio-venous Fistula
- What is being tested?
- Supraclavicular nerve block
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Jan 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: All patients undergoing shunt surgery under supraclavicular plexus block
Who may be able to join
- all patients undergoing surgery under regional anaesthesia
Who cannot join
- patients refusal
Trial locations and contacts
1 site in 1 country.
Germany1 site
Marienhospital Stuttgart, Dpt. of Anaesthesiology
Stuttgart, Baden-Wurttemberg, 70199
About this study
Official title: Near-infrared Spectroscopy to Assess Changes in Tissue Oxygenation Following Supraclavicular Plexus Block in Patients Undergoing Vascular Surgery
Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes causing increased arterial blood flow and venodilatation .
Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing oxygen saturation by detecting the absorption and reflection of near-infrared light .
The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula revision has not yet been examined. We postulate an increase in tissue oxygenation by sympathicolysis caused by peripheral regional anesthesia that might be the reason for beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular plexus block in this group of patients.
- Conditions
- Arterio-venous Fistula
- Being tested
- Supraclavicular nerve block
- Keywords
- NIR Spectroscopy, Nerve Blockade, Surgical Arteriovenous Shunt
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular nerve blockDrug
Supraclavicular nerve block using ultrasound and 10ml ropivacaine 0.5% with 20ml mepivacaine 1%
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular Nerve Block | Patients undergoing vascular surgery for creation or revision of an arterio-venous fistula. Intervention: supraclavicular plexus block for anaesthesia. NIRS measurement before and after brachial plexus block. Receives: Drug: Supraclavicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIRS after block
Absolute change from baseline value in tissue oxygenation
Measured: 5 minutes before block until 30 minutes after block
Secondary outcomes (1)
Difference between both arms
Absolute difference in tissue oxygenation between blocked arm and contralateral arm
Measured: 5 minutes before block until 30 minutes after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startSep 2016
- Primary completionSep 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterio-venous FistulaStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marienhospital Stuttgart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christoph Ilies, Marienhospital Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044496
- Sponsor's protocol ID
- NIRS after SCP block
- Status last verified
- Apr 2018
- First submitted
- 31 Jan 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keuler J, Weiss C, Klemm K, Pochhammer J, Schmidt R, Ilies C. Assessing changes in tissue oxygenation by near-infrared spectroscopy following brachial plexus block for arteriovenous fistula surgery: A prospective observational pilot study. Eur J Anaesthesiol. 2018 Oct;35(10):759-765. doi: 10.1097/EJA.0000000000000871.
PubMed 30124502
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Spectroscopy to Assess Changes in Tissue Oxygenation Following Supraclavicular Plexus Block in Patients Undergoing Vascular Surgery
- ClinicalTrials.gov ID
- NCT03044496
- Acronym / sponsor ID
- NIRS after SCP block
- Conditions
- Arterio-venous Fistula
- Keywords
- NIR Spectroscopy, Nerve Blockade, Surgical Arteriovenous Shunt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Marienhospital StuttgartUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Feb 2017 (estimated)
- 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.
Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes causing increased arterial blood flow and venodilatation .
Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing oxygen saturation by detecting the absorption and reflection of near-infrared light .
The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula revision has not yet been examined. We postulate an increase in tissue oxygenation by sympathicolysis caused by peripheral regional anesthesia that might be the reason for beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular plexus block in this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular Nerve Block | – | Drug: Supraclavicular nerve blockPatients undergoing vascular surgery for creation or revision of an arterio-venous fistula. Intervention: supraclavicular plexus block for anaesthesia. NIRS measurement before and after brachial plexus block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing shunt surgery under supraclavicular plexus block
Key inclusion criteria (1 listed)
- all patients undergoing surgery under regional anaesthesia
Key exclusion criteria (1 listed)
- patients refusal
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 |
|---|---|---|
| Supraclavicular nerve blockSupraclavicular nerve block using ultrasound and 10ml ropivacaine 0.5% with 20ml mepivacaine 1% | Drug | Supraclavicular Nerve Block |
Primary outcome
NIRS after block
Time frame: 5 minutes before block until 30 minutes after block
Absolute change from baseline value in tissue oxygenation
1 secondary outcome
Difference between both arms
Time frame: 5 minutes before block until 30 minutes after block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Derived from this study: PubMed 30124502Keuler J, Weiss C, Klemm K, Pochhammer J, Schmidt R, Ilies C. Assessing changes in tissue oxygenation by near-infrared spectroscopy following brachial plexus block for arteriovenous fistula surgery: A prospective observational pilot study. Eur J Anaesthesiol. 2018 Oct;35(10):759-765. doi: 10.1097/EJA.0000000000000871.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arterio-venous Fistula, run by Marienhospital Stuttgart 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: finished, as of the sponsor's last update on 12 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIRS after block (time frame: 5 minutes before block until 30 minutes after block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03044496, which also lists 1 linked publication.
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 12 Apr 2018.