AnesthesiaeZonoNCT01122693
Comparison Between Two Ultrasound Technologies for Ultrasound-guided Catheter Placement in Regional Anesthesia
A study testing eZono - high-quality 2D ultrasound images and standard 2D ultrasound images in people with Anesthesia, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The use of ultrasound imaging techniques in regional anaesthesia is rapidly becoming an area of increasing interest. It represents one of the largest changes that the field of regional anaesthesia has seen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- eZono - high-quality 2D ultrasound images and standard 2D ultrasound images
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2010to Jul 2011
- Phase
- Interventional
- 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
Who may be able to join
- Patients at the age of 18 and above who need a regional anesthesia catheter for postoperative pain management after elective orthopedic surgery
Who cannot join
- Participation in another trial according to the German Drug Law 30 days to and during the study
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- (Unclear) history of alcohol or substances disabuse
- Absent knowledge of German language
- Analphabetism
Show all 22Show fewer
- Allergy to local anesthesia or other ingredients of the intravenous solutions
- For women: Pregnancy or positive pregnancy test within the preoperative screening
- Operation due to case of emergency, polytrauma or pathologic fracture
- American Society of Anaesthesiologists (ASA) classification greater than III
- Peripheral or central edema
- AIDS (according to the CDC-classification of HIV-infection: category C)
- Immunosuppression therapy
- History of bleeding tendency (e.g. von-Willebrand-disease, thrombocytopenia)
- Derailed metabolic disorder (e.g. Diabetes mellitus (Glucose > 300 mg/dl) during the preoperative screening)
- Known history of electrolyte disturbance (e.g. Hyperkalemia > 5.8 mmol/l, Hypernatraemia > 155 mmol/l)
- Known history of acid-base-dysbalances
- History of intracranial hemorrhage within one year of participation in the study
- Neurological or psychiatric disease with limited contractual capability
- CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV
- Liver disease (CHILD B or C cirrhosis, end-stage liver disease (MELD-score greater than 10)
- Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie
Berlin, State of Berlin, 10117
Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Berlin, State of Berlin, 10117
About this study
Official title: A Prospective, Randomized Comparison Between Two Ultrasound Technologies for Ultrasound-guided Catheter Placement in Regional Anesthesia
The use of ultrasound imaging techniques in regional anaesthesia is rapidly becoming an area of increasing interest. It represents one of the largest changes that the field of regional anaesthesia has seen. For the first time, the operator is able to view an image of the target nerve directly, guide the needle under real-time observation, navigate away from sensitive anatomy, and monitor the spread of local anaesthetic (LA).The key to successful regional anaesthesia is deposition of LA accurately around the nerve structures.
In the past, electrical stimulation which relied on surface landmark identification, was used for this. However, landmark techniques have limitations; variations in anatomy and nerve physiology , as well as equipment accuracy have had an effect on success rates and complications.
Read more
However, alongside the enthusiasm of ultrasound guidance in regional anaesthesia, there should be a degree of informed scepticism. The widespread use of the various techniques of ultrasound-guided regional blocks without adequate training raises the danger of malpractice and subsequent impaired outcome.
Adequate education in the use of regional block techniques under ultrasound guidance is essential. Recent technical developments have achieved higher ultrasound frequencies and better image resolution, as well as better post-processing and user-friendliness.
The purpose of this study is to determine whether new technical features such as reference images, higher ultrasound frequencies, better image resolution and smaller size and weight of the ultrasound probes may improve outcome (clinical benefits) and may show an increased efficacy and safety. And if the new technology of ultrasound images improves the training quality of trainees and novices in the art of ultrasound-guided blocks.
- Conditions
- Anesthesia
- Being tested
- eZono - high-quality 2D ultrasound images, standard 2D ultrasound images
- Keywords
- Regional Anesthesia, Pain Medicine, Ultrasound, Nerve Blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eZono - high-quality 2D ultrasound imagesDevice
higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.
standard 2D ultrasound imagesDevice
current standard in two-dimensional (2D) ultrasound images
| Study group | Role | What they receive |
|---|---|---|
| standard 2D ultrasound images | Active comparator | Not described Receives: Device: eZono - high-quality 2D ultrasound images; Device: standard 2D ultrasound images |
| high-quality 2D ultrasound images | Experimental | Not described Receives: Device: eZono - high-quality 2D ultrasound images; Device: standard 2D ultrasound images |
| nerve stimulation techniques | Active comparator | Not described Receives: Device: eZono - high-quality 2D ultrasound images; Device: standard 2D ultrasound images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in time to perform the catheter placement in regional anesthesia
Measured: first three days
Secondary outcomes (2)
Improvement in performance: Incidence of complications
Measured: first three days
Improvement of success rate regarding correct catheter placement
Measured: first three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122693
- Sponsor's protocol ID
- eZono
- Acronym
- eZono
- Status last verified
- Feb 2016
- First submitted
- 10 May 2010
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison Between Two Ultrasound Technologies for Ultrasound-guided Catheter Placement in Regional Anesthesia
- ClinicalTrials.gov ID
- NCT01122693
- Acronym / sponsor ID
- eZono / eZono
- Conditions
- Anesthesia
- Keywords
- Regional Anesthesia, Pain Medicine, Ultrasound, Nerve Blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 May 2010 (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.
The use of ultrasound imaging techniques in regional anaesthesia is rapidly becoming an area of increasing interest. It represents one of the largest changes that the field of regional anaesthesia has seen. For the first time, the operator is able to view an image of the target nerve directly, guide the needle under real-time observation, navigate away from sensitive anatomy, and monitor the spread of local anaesthetic (LA).The key to successful regional anaesthesia is deposition of LA accurately around the nerve structures.
In the past, electrical stimulation which relied on surface landmark identification, was used for this. However, landmark techniques have limitations; variations in anatomy and nerve physiology , as well as equipment accuracy have had an effect on success rates and complications.
However, alongside the enthusiasm of ultrasound guidance in regional anaesthesia, there should be a degree of informed scepticism. The widespread use of the various techniques of ultrasound-guided regional blocks without adequate training raises the danger of malpractice and subsequent impaired outcome.
Adequate education in the use of regional block techniques under ultrasound guidance is essential. Recent technical developments have achieved higher ultrasound frequencies and better image resolution, as well as better post-processing and user-friendliness.
The purpose of this study is to determine whether new technical features such as reference images, higher ultrasound frequencies, better image resolution and smaller size and weight of the ultrasound probes may improve outcome (clinical benefits) and may show an increased efficacy and safety. And if the new technology of ultrasound images improves the training quality of trainees and novices in the art of ultrasound-guided blocks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard 2D ultrasound images | Active comparator | Device: eZono - high-quality 2D ultrasound images, Device: standard 2D ultrasound images |
| high-quality 2D ultrasound images | Experimental | Device: eZono - high-quality 2D ultrasound images, Device: standard 2D ultrasound images |
| nerve stimulation techniques | Active comparator | Device: eZono - high-quality 2D ultrasound images, Device: standard 2D ultrasound images |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at the age of 18 and above who need a regional anesthesia catheter for postoperative pain management after elective orthopedic surgery
Key exclusion criteria (22 listed)
- Participation in another trial according to the German Drug Law 30 days to and during the study
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- (Unclear) history of alcohol or substances disabuse
- Absent knowledge of German language
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 |
|---|---|---|
| eZono - high-quality 2D ultrasound imageshigher ultrasound frequencies, better image resolution, better post-processing and user-friendliness. | Device | high-quality 2D ultrasound images, nerve stimulation techniques, standard 2D ultrasound images |
| standard 2D ultrasound imagescurrent standard in two-dimensional (2D) ultrasound images | Device | high-quality 2D ultrasound images, nerve stimulation techniques, standard 2D ultrasound images |
Primary outcome
Reduction in time to perform the catheter placement in regional anesthesia
Time frame: first three days
2 secondary outcomes
Improvement in performance: Incidence of complications
Time frame: first three days
Improvement of success rate regarding correct catheter placement
Time frame: first three days
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 4 Feb 2016.
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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.
Claudia Spies, MD Prof. study director
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eZono - high-quality 2D ultrasound images and standard 2D ultrasound images in people with Anesthesia, run by Charite University, Berlin, Germany at 2 sites 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 22 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Reduction in time to perform the catheter placement in regional anesthesia (time frame: first three days). 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 4 Feb 2016.