Learning Anesthesia ProceduresNCT05889923
Training and Evaluation of Ultrasound-Guided Procedures
A study testing With EDU in people with Learning Anesthesia Procedures, run by Clear Guide Medical at 1 site in United States.
Trial summary
38 certified registered nurse anesthetist (CRNA) students will learn 5 different ultrasound-guided regional anesthesia blocks both with and without a novel device, the EDU which gives the student help finding the right needle path. Read more about this study
- Who is it for?
- Ages 22 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning Anesthesia Procedures
- What is being tested?
- With EDU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 31 Dec 2022
- 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 22 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: All CRNA students in Dr. Hauglum's class on ultrasound-guided nerve blocks -
Exclusion Criteria: Any CRNA students who drop Dr. Hauglum's class on ultrasound-guided nerve blocks
-
Trial locations and contacts
1 site in 1 country.
About this study
38 certified registered nurse anesthetist (CRNA) students will learn 5 different ultrasound-guided regional anesthesia blocks both with and without a novel device, the EDU which gives the student help finding the right needle path.
Read the detailed description
38 students enrolled in a course for ultrasound-guided nerve blocks will be participants in a study to evaluate the benefit of learning with ultrasound guidance. The EDU, a computer assisted guide for ultrasound interventions will be used for half the students for each of 5 nerve blocks/interventional procedures. Then the students will switch (crossover study) and perform the same interventions. Data will be recorded by dint of the tiny video cameras on the EDU and anonymized and evaluated.
- Conditions
- Learning Anesthesia Procedures
- Being tested
- With EDU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With EDUDevice
using the EDU to perform the procedure
| Study group | Role | What they receive |
|---|---|---|
| learning with the EDU | Experimental | Students will perform 5 ultrasound-guided regional anesthesia procedures on a phantom using the EDU which shows the student how to hold the needle and probe to hit the target. Receives: Device: With EDU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance to target
how close did the student come to the instructor-specified target
Measured: Day 1
number of redirects
how many times did the student withdraw the needle and start again
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start16 Aug 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning Anesthesia ProceduresStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Guide Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889923
- Sponsor's protocol ID
- UMiami 2021
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 5 Jun 2023
- 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 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training and Evaluation of Ultrasound-Guided Procedures
- ClinicalTrials.gov ID
- NCT05889923
- Acronym / sponsor ID
- UMiami 2021
- Conditions
- Learning Anesthesia Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Clear Guide MedicalIndustry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jun 2023 (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.
38 certified registered nurse anesthetist (CRNA) students will learn 5 different ultrasound-guided regional anesthesia blocks both with and without a novel device, the EDU which gives the student help finding the right needle path.
Detailed description
38 students enrolled in a course for ultrasound-guided nerve blocks will be participants in a study to evaluate the benefit of learning with ultrasound guidance. The EDU, a computer assisted guide for ultrasound interventions will be used for half the students for each of 5 nerve blocks/interventional procedures. Then the students will switch (crossover study) and perform the same interventions. Data will be recorded by dint of the tiny video cameras on the EDU and anonymized and evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| learning with the EDU | Experimental | Device: With EDUStudents will perform 5 ultrasound-guided regional anesthesia procedures on a phantom using the EDU which shows the student how to hold the needle and probe to hit the target. |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| With EDUusing the EDU to perform the procedure | Device | learning with the EDU |
Primary outcome
Distance to target
Time frame: Day 1
how close did the student come to the instructor-specified target
number of redirects
Time frame: Day 1
how many times did the student withdraw the needle and start again
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 5 Jun 2023.
- 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?
A study testing With EDU in people with Learning Anesthesia Procedures, run by Clear Guide Medical 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?
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 5 Jun 2023. 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?
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?
Distance to target (time frame: Day 1). The study lists 2 primary outcomes in all. 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 5 Jun 2023.