Simulator-based Training of Ultrasound-guided Regional AnesthesiaNCT02032420
The Effects of the STAR Maneuver on UGRA Training
A study testing STAR and ART in people with Simulator-based Training of Ultrasound-guided Regional Anesthesia, run by University of New Mexico at 1 site in United States.
Trial summary
Volunteers will watch a training video demonstrating how to place a needle in the correct position while keeping it visible. Later the volunteers will be placed in front of a set up identical to the video, and asked to demonstrate how to direct an 80 mm echogenic Pajunk needle into 3 targets in a standardized homemade… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulator-based Training of Ultrasound-guided Regional Anesthesia
- What is being tested?
- STAR and ART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Right handed
- Aged 18 to 55
Who cannot join
- Any person who has prior knowledge about ultrasound imaging or regional anesthesia
- Any person who has prior experience with laparoscopy or biopsy
- Any person who has problems with depth of field or simple hand eye co-ordination task
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
About this study
Official title: A Double Blinded Randomized Controlled Trial on the Effects of Four Sequential Maneuvers on Ultrasound Guided Nerve Block Performance
Volunteers will watch a training video demonstrating how to place a needle in the correct position while keeping it visible. Later the volunteers will be placed in front of a set up identical to the video, and asked to demonstrate how to direct an 80 mm echogenic Pajunk needle into 3 targets in a standardized homemade phantom a total of three times.
Read the detailed description
After watching the training video, each volunteer will be placed in front of a set up identical to the video seen. Adjacent to this set up, a single fellowship trained regional anesthesiologist known as the assessor is situated with a screen that allows real time viewing of the ultrasound screen seen by the volunteer. The assessor is blinded to the assignment of the volunteer. Also, the assessor does not have any visualization of the volunteer. This prevents visualizing hand or body movement that may cause a bias. The same assessor is used for the whole study to provide consistent assessment of the task.
The task involves the volunteer directing an 80 mm echogenic Pajunk needle into 3 targets in a standardized homemade phantom. The targets simulate the nerve roots commonly found in the interscalene block. Thus, they are arranged diagonally to simulate the nerve root position commonly seen. Also, they are arranged on a tilt relative to the flat surface of the phantom to simulate the direction the nerve travels. This is important as the tilt of the target requires the volunteer to tilt the probe so that their incidental ultrasound wave is perpendicular to the target for the brightest reflection to occur. This phenomenon is known as anisotropy. This increases the realism of the task that cannot be imitated by commercially available phantoms.
There are 3 goals that the volunteer must fulfill in performing their task. Firstly, they must direct the needle to the 12 o'clock position of the 3 targets. Secondly, they must achieve maximal ultrasound image brightness of the 3 targets at all times. Thirdly, the entire needle must be visualized at all times.
If the needle is not in the correct position, the assessor will verbally inform the volunteer to redirect it to the correct position. If the target images are not at their brightest, the assessor will verbally inform the volunteer not to manipulate the needle towards the target until the targets are at their brightest. Clinically, this functions to prevent the needle being inserted inside the nerve as the targets are not clearly seen. Thirdly, if the needle is visualized entirely, the volunteer will be told to stop manipulating the needle towards the target until the needle is fully visualized by manipulating the probe. A timer records the cumulative time the needle is not in full visualization. Clinically, this functions to prevent the needle being inserted into a nerve or structure that it should not.
After all 3 targets have been completed, the volunteer repeats the task a total of 3 times.
- Being tested
- STAR, ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARBehavioural
ARTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| STAR | Experimental | Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate. Receives: Behavioral: STAR |
| ART | Active comparator | Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt. Receives: Behavioral: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task Completion Time
Median time taken to complete 3 iterations of the assigned task, across participants within a study arm
Measured: Immediately after training
Secondary outcomes (2)
Needle-not-seen Time
Median percentage of attempt time on 3 iterations in which the needle is not adequately visualized, across participants within a study arm
Measured: During attempt
Performer Fatigue
Self-reported trainee fatigue on a numerical rating scale (1= least fatigued; 10=most fatigued); lower scores indicate less fatigue
Measured: During task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Simulator-based Training of Ultrasound-guided Regional AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy R Petersen, University of New Mexico
- Investigators
- Nicholas Lam, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032420
- Sponsor's protocol ID
- STAR vs. ART
- Status last verified
- Dec 2016
- First submitted
- 18 Dec 2013
- Last updated
- 13 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded Randomized Controlled Trial on the Effects of Four Sequential Maneuvers on Ultrasound Guided Nerve Block Performance
- ClinicalTrials.gov ID
- NCT02032420
- Acronym / sponsor ID
- STAR vs. ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Posted 13 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Volunteers will watch a training video demonstrating how to place a needle in the correct position while keeping it visible. Later the volunteers will be placed in front of a set up identical to the video, and asked to demonstrate how to direct an 80 mm echogenic Pajunk needle into 3 targets in a standardized homemade phantom a total of three times.
Detailed description
After watching the training video, each volunteer will be placed in front of a set up identical to the video seen. Adjacent to this set up, a single fellowship trained regional anesthesiologist known as the assessor is situated with a screen that allows real time viewing of the ultrasound screen seen by the volunteer. The assessor is blinded to the assignment of the volunteer. Also, the assessor does not have any visualization of the volunteer. This prevents visualizing hand or body movement that may cause a bias. The same assessor is used for the whole study to provide consistent assessment of the task.
The task involves the volunteer directing an 80 mm echogenic Pajunk needle into 3 targets in a standardized homemade phantom. The targets simulate the nerve roots commonly found in the interscalene block. Thus, they are arranged diagonally to simulate the nerve root position commonly seen. Also, they are arranged on a tilt relative to the flat surface of the phantom to simulate the direction the nerve travels. This is important as the tilt of the target requires the volunteer to tilt the probe so that their incidental ultrasound wave is perpendicular to the target for the brightest reflection to occur. This phenomenon is known as anisotropy. This increases the realism of the task that cannot be imitated by commercially available phantoms.
There are 3 goals that the volunteer must fulfill in performing their task. Firstly, they must direct the needle to the 12 o'clock position of the 3 targets. Secondly, they must achieve maximal ultrasound image brightness of the 3 targets at all times. Thirdly, the entire needle must be visualized at all times.
If the needle is not in the correct position, the assessor will verbally inform the volunteer to redirect it to the correct position. If the target images are not at their brightest, the assessor will verbally inform the volunteer not to manipulate the needle towards the target until the targets are at their brightest. Clinically, this functions to prevent the needle being inserted inside the nerve as the targets are not clearly seen. Thirdly, if the needle is visualized entirely, the volunteer will be told to stop manipulating the needle towards the target until the needle is fully visualized by manipulating the probe. A timer records the cumulative time the needle is not in full visualization. Clinically, this functions to prevent the needle being inserted into a nerve or structure that it should not.
After all 3 targets have been completed, the volunteer repeats the task a total of 3 times.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAR | Experimental | Behavioral: STARIntroductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate. |
| ART | Active comparator | Behavioral: ARTIntroductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Right handed
- Aged 18 to 55
Key exclusion criteria (3 listed)
- Any person who has prior knowledge about ultrasound imaging or regional anesthesia
- Any person who has prior experience with laparoscopy or biopsy
- Any person who has problems with depth of field or simple hand eye co-ordination task
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 |
|---|---|---|
| STAR | Behavioural | STAR |
| ART | Behavioural | ART |
Primary outcome
Task Completion Time
Time frame: Immediately after training
Median time taken to complete 3 iterations of the assigned task, across participants within a study arm
2 secondary outcomes
Needle-not-seen Time
Time frame: During attempt
Performer Fatigue
Time frame: During task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Nicholas Lam principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR and ART in people with Simulator-based Training of Ultrasound-guided Regional Anesthesia, run by University of New Mexico at 1 site in United States.
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 3 inclusion and 3 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 13 Feb 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Task Completion Time (time frame: Immediately after training). 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 13 Feb 2017.