Anesthesia, LocalVisibilityNCT03231696
Visibility - Classification of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks
An observational study of Anesthesia, Local and Anesthesia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Anesthesia
- How many people
- 1,200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Dec 2016
- 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 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016.
Who may be able to join
- peripheral nerve block by ultrasound guidance
- age ≥ 18 years
- peripheral nerve block by ultrasound guidance
- age ≥ 18 years
Who cannot join
- contraindications for regional anesthesia
- contraindications for regional anesthesia (study sample n=46)
- using not the standard ultrasound machine
- performing not a standard regional anesthesia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
Berlin, 10117
About this study
Official title: Visibility - A Novel Classification Score of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.
Read the detailed description
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.
VIS(visibility) 1 easy identification and instant visualisation of all structures VIS 2 identification and visualisation of all structures after some corrections VIS 3 identification and visualisation of structures only unsure VIS 4 identification and visualisation of all structures impossible VIS 5 no structures seen. We amended a sub-project in which assessed the visibility in protective nerve stimulated nerve blocks in 46 patients.
- Conditions
- Anesthesia, Local, Anesthesia
- Keywords
- nerve block, peripheral nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Regional Anesthesia | All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility
The ultrasound visibility of the nerve scored by a 5-step scale.
Measured: During regional block (an average of 1 hour)
Secondary outcomes (1)
Additional analgesia
The need and amount of additional analgetic drugs while the intervention.
Measured: During surgery (an average of 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study startJan 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurgen Birnbaum, Charite University, Berlin, Germany
- Investigators
- Jürgen Birnbaum, MD, Principal investigator, Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231696
- Sponsor's protocol ID
- Visibility
- Acronym
- Visibility
- Status last verified
- Dec 2017
- First submitted
- 25 Jul 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visibility - A Novel Classification Score of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks
- ClinicalTrials.gov ID
- NCT03231696
- Acronym / sponsor ID
- Visibility / Visibility
- Conditions
- Anesthesia, Local, Anesthesia
- Keywords
- nerve block, peripheral nerve stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jul 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.
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.
Detailed description
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.
VIS(visibility) 1 easy identification and instant visualisation of all structures VIS 2 identification and visualisation of all structures after some corrections VIS 3 identification and visualisation of structures only unsure VIS 4 identification and visualisation of all structures impossible VIS 5 no structures seen. We amended a sub-project in which assessed the visibility in protective nerve stimulated nerve blocks in 46 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Regional Anesthesia | – | –All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016.
Key inclusion criteria (4 listed)
- peripheral nerve block by ultrasound guidance
- age ≥ 18 years
- peripheral nerve block by ultrasound guidance
- age ≥ 18 years
Key exclusion criteria (4 listed)
- contraindications for regional anesthesia
- contraindications for regional anesthesia (study sample n=46)
- using not the standard ultrasound machine
- performing not a standard regional anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visibility
Time frame: During regional block (an average of 1 hour)
The ultrasound visibility of the nerve scored by a 5-step scale.
1 secondary outcome
Additional analgesia
Time frame: During surgery (an average of 4 hours)
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 15 Dec 2017.
- 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.
Jürgen Birnbaum, MD principal investigator
Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
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 Anesthesia, Local and Anesthesia, run by Charite University, Berlin, Germany 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 4 inclusion and 4 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 15 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?
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?
Visibility (time frame: During regional block (an average of 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 15 Dec 2017.