UltrasoundNCT05013476
Tele-Ultrasound: VIrtual Hands-on Education for Novice Users
A study testing Butterfly handheld ultrasound machine in people with Ultrasound and Education, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is intended to perform a comparative analysis of novice ultrasound users when taught in person versus virtually. This study aims to show that students will not demonstrate a statistical difference in scores learning in in a virtual environment, guided by professionals, when compared to students learning… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, Education, Virtual
- What is being tested?
- Butterfly handheld ultrasound machine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 4 Oct 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First year medical students enrolled at the University of Colorado, Anschutz Medical Campus with minimal previous ultrasound experience.
- First year graduate students enrolled in the Modern Human Anatomy program (MHA) at the University of Colorado, Anschutz Medical Campus with minimal previous ultrasound experience.
Who cannot join
- individuals younger than the age of 18.
- individuals not enrolled in the medical school or Modern Human Anatomy program (MHA) programs at Anschutz Medical Campus
- Individuals with greater than minimal ultrasound experience.
Trial locations and contacts
1 site in 1 country.
About this study
This study is intended to perform a comparative analysis of novice ultrasound users when taught in person versus virtually. This study aims to show that students will not demonstrate a statistical difference in scores learning in in a virtual environment, guided by professionals, when compared to students learning ultrasound in a traditional, in-person format. Utilizing a Butterfly ultrasound machine, a hand held personal ultrasound device, students wil be guided through a FAST (Focused assessment with sonography in trauma) examination and imaging of the carpal tunnel using modules and instructor aid. The FAST (Focused assessment with sonography in trauma) exam images the heart and abdomen for free flowing blood. The carpal tunnel is a region in the wrist that houses the tendons for finger movement. Participants will be assessed on the ability to identify key regions, anatomical landmarks and confidence in utilize the ultrasound machine.
Read the detailed description
This project intends to adapt previous research ("Innovations with tele-ultrasound in education sonography: the use of tele-ultrasound to train novice scanners") to assess the effectiveness of tele-education using the Butterfly handheld ultrasound device when compared to in person education imaging devices, learning modules and assessments will be kept constant across experimental groups. This experiment aims to adapt the current ultrasound modules used by the University of Colorado Anschutz school of Medicine and Modern Human Anatomy program to formulate in depth modules that outline the following: Carpal Tunnel (wrist), Brachial Plexus (shoulder), and FAST "Focused Assessment with Sonography in Trauma". Additionally, participants will be provided an orientation module that will be completed prior to the live session. Participants will be divided into either the in-person group or virtual group and participate in a live session where participants go through each module with a trained instructor. Participants will be asked to complete a pre/post assessment to determine prior knowledge and the level of learning that took place during the session as well as participant satisfaction and confidence levels.
- Conditions
- Ultrasound, Education, Virtual
- Being tested
- Butterfly handheld ultrasound machine
- Keywords
- tele-education, ultrasound, FAST, Carpal Tunnel
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butterfly handheld ultrasound machineCombination product
Also called Zoom
Both arms of study will utilize the Butterfly ultrasound machine. Only the virtual learners will utilize zoom for their virtual education
| Study group | Role | What they receive |
|---|---|---|
| In-Person ultrasound participants | Active comparator | In-Person ultrasound participant's will receive ultrasound training that is guided by online modules (identical to virtual) with trained faculty in the same room with a ration of 4 students to 1 instructor. Receives: Combination Product: Butterfly handheld ultrasound machine |
| Virtual ultrasound participants | Active comparator | Virtual ultrasound participants will receive ultrasound training that is guided by online modules (identical to in-person) with trained faculty present in a private zoom classroom. Faculty will be rotating between breakout rooms and will share the same ratio of participants to staff. Receives: Combination Product: Butterfly handheld ultrasound machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of participant assesment scores when asked to identify key features of the FAST and Carpal Tunnel between in person learners and virtual learners.
Scores are measured on a pass (1) or fail (0) grading system with a total number of 17 points per participant. An Anderson-Darling test will determine if the data is normally distributed. If the data demonstrates normal distribution, either a parametric analysis via a two-way ANOVA or non-parametric equivalent analysis via pairwise Mann-Whitney U will be performed to compare responses from the different groups. Further a Bran-Altman Test will be considered.
Measured: 10 minutes
Secondary outcomes (2)
Student comparative confidence levels in ultrasound between virtual learners and in-person learners.
Likert Scale measures participant's subjective opinion on a question. Five answer choices are provided on a scale of 0 to 5 with an extreme on both ends, a neutral choice and a middle ground answer for both ends of the spectrum. A higher score represents a greater degree of confidence in the material. Lower scores indicate little to no confidence in the material.
Measured: 1.5 hours
Student comparative satisfaction levels in ultrasound between virtual learners and in-person learners.
Likert Scale measures participant's subjective opinion on a question. Five answer choices are provided on a scale of 0 to 5 with an extreme on both ends, a neutral choice and a middle ground answer for both ends of the spectrum. Higher scores indicate high satisfaction levels with the learning modality. Low scores indicate that participant's did not enjoy the learning modality.
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start30 Sep 2021
- Primary completion4 Oct 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be divided into 2 groups which will experience different experimental conditions.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- logan T scott, B.S., Principal investigator, Graduate Student, Masters in Modern Human Anatomy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013476
- Sponsor's protocol ID
- 21-3964
- Status last verified
- Jan 2024
- First submitted
- 16 Aug 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared with other researchers. Statistical analysis and results will be shared.
Publications
Drake AE, Hy J, MacDougall GA, Holmes B, Icken L, Schrock JW, Jones RA. Innovations with tele-ultrasound in education sonography: the use of tele-ultrasound to train novice scanners. Ultrasound J. 2021 Feb 14;13(1):6. doi: 10.1186/s13089-021-00210-0.
PubMed 33586112Royer DF, Kessler R, Stowell JR. Evaluation of an innovative hands-on anatomy-centered ultrasound curriculum to supplement graduate gross anatomy education. Anat Sci Educ. 2017 Jul;10(4):348-362. doi: 10.1002/ase.1670. Epub 2016 Nov 21.
PubMed 27870531Dietrich CF, Hoffmann B, Abramowicz J, Badea R, Braden B, Cantisani V, Chammas MC, Cui XW, Dong Y, Gilja OH, Hari R, Nisenbaum H, Nicholls D, Nolsoe CP, Nurnberg D, Prosch H, Radzina M, Recker F, Sachs A, Saftoiu A, Serra A, Sweet L, Vinayak S, Westerway S, Chou YH, Blaivas M. Medical Student Ultrasound Education: A WFUMB Position Paper, Part I. Ultrasound Med Biol. 2019 Feb;45(2):271-281. doi: 10.1016/j.ultrasmedbio.2018.09.017. Epub 2018 Nov 27.
PubMed 30497768
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Ultrasound: VIrtual Hands-on Education for Novice Users
- ClinicalTrials.gov ID
- NCT05013476
- Acronym / sponsor ID
- 21-3964
- Conditions
- Ultrasound, Education, Virtual
- Keywords
- tele-education, ultrasound, FAST, Carpal Tunnel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 19 Aug 2021 (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.
This study is intended to perform a comparative analysis of novice ultrasound users when taught in person versus virtually. This study aims to show that students will not demonstrate a statistical difference in scores learning in in a virtual environment, guided by professionals, when compared to students learning ultrasound in a traditional, in-person format. Utilizing a Butterfly ultrasound machine, a hand held personal ultrasound device, students wil be guided through a FAST (Focused assessment with sonography in trauma) examination and imaging of the carpal tunnel using modules and instructor aid. The FAST (Focused assessment with sonography in trauma) exam images the heart and abdomen for free flowing blood. The carpal tunnel is a region in the wrist that houses the tendons for finger movement. Participants will be assessed on the ability to identify key regions, anatomical landmarks and confidence in utilize the ultrasound machine.
Detailed description
This project intends to adapt previous research ("Innovations with tele-ultrasound in education sonography: the use of tele-ultrasound to train novice scanners") to assess the effectiveness of tele-education using the Butterfly handheld ultrasound device when compared to in person education imaging devices, learning modules and assessments will be kept constant across experimental groups. This experiment aims to adapt the current ultrasound modules used by the University of Colorado Anschutz school of Medicine and Modern Human Anatomy program to formulate in depth modules that outline the following: Carpal Tunnel (wrist), Brachial Plexus (shoulder), and FAST "Focused Assessment with Sonography in Trauma". Additionally, participants will be provided an orientation module that will be completed prior to the live session. Participants will be divided into either the in-person group or virtual group and participate in a live session where participants go through each module with a trained instructor. Participants will be asked to complete a pre/post assessment to determine prior knowledge and the level of learning that took place during the session as well as participant satisfaction and confidence levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be divided into 2 groups which will experience different experimental conditions.
| Arm | Type | Receives |
|---|---|---|
| In-Person ultrasound participants | Active comparator | Combination Product: Butterfly handheld ultrasound machineIn-Person ultrasound participant's will receive ultrasound training that is guided by online modules (identical to virtual) with trained faculty in the same room with a ration of 4 students to 1 instructor. |
| Virtual ultrasound participants | Active comparator | Combination Product: Butterfly handheld ultrasound machineVirtual ultrasound participants will receive ultrasound training that is guided by online modules (identical to in-person) with trained faculty present in a private zoom classroom. Faculty will be rotating between breakout rooms and will share the same ratio of participants to staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First year medical students enrolled at the University of Colorado, Anschutz Medical Campus with minimal previous ultrasound experience.
- First year graduate students enrolled in the Modern Human Anatomy program (MHA) at the University of Colorado, Anschutz Medical Campus with minimal previous ultrasound experience.
Key exclusion criteria (3 listed)
- individuals younger than the age of 18.
- individuals not enrolled in the medical school or Modern Human Anatomy program (MHA) programs at Anschutz Medical Campus
- Individuals with greater than minimal ultrasound experience.
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 |
|---|---|---|
| Butterfly handheld ultrasound machineAlso: ZoomBoth arms of study will utilize the Butterfly ultrasound machine. Only the virtual learners will utilize zoom for their virtual education | Combination product | In-Person ultrasound participants, Virtual ultrasound participants |
Primary outcome
Comparison of participant assesment scores when asked to identify key features of the FAST and Carpal Tunnel between in person learners and virtual learners.
Time frame: 10 minutes
Scores are measured on a pass (1) or fail (0) grading system with a total number of 17 points per participant. An Anderson-Darling test will determine if the data is normally distributed. If the data demonstrates normal distribution, either a parametric analysis via a two-way ANOVA or non-parametric equivalent analysis via pairwise Mann-Whitney U will be performed to compare responses from the different groups. Further a Bran-Altman Test will be considered.
2 secondary outcomes
Student comparative confidence levels in ultrasound between virtual learners and in-person learners.
Time frame: 1.5 hours
Student comparative satisfaction levels in ultrasound between virtual learners and in-person learners.
Time frame: 1.5 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 31 Jan 2024.
- Background: PubMed 33586112Drake AE, Hy J, MacDougall GA, Holmes B, Icken L, Schrock JW, Jones RA. Innovations with tele-ultrasound in education sonography: the use of tele-ultrasound to train novice scanners. Ultrasound J. 2021 Feb 14;13(1):6. doi: 10.1186/s13089-021-00210-0.
- Background: PubMed 27870531Royer DF, Kessler R, Stowell JR. Evaluation of an innovative hands-on anatomy-centered ultrasound curriculum to supplement graduate gross anatomy education. Anat Sci Educ. 2017 Jul;10(4):348-362. doi: 10.1002/ase.1670. Epub 2016 Nov 21.
- Background: PubMed 30497768Dietrich CF, Hoffmann B, Abramowicz J, Badea R, Braden B, Cantisani V, Chammas MC, Cui XW, Dong Y, Gilja OH, Hari R, Nisenbaum H, Nicholls D, Nolsoe CP, Nurnberg D, Prosch H, Radzina M, Recker F, Sachs A, Saftoiu A, Serra A, Sweet L, Vinayak S, Westerway S, Chou YH, Blaivas M. Medical Student Ultrasound Education: A WFUMB Position Paper, Part I. Ultrasound Med Biol. 2019 Feb;45(2):271-281. doi: 10.1016/j.ultrasmedbio.2018.09.017. Epub 2018 Nov 27.
- Individual participant dataSharing planned: No. Participant data will not be shared with other researchers. Statistical analysis and results will be shared.
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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.
logan T scott, B.S. principal investigator
Graduate Student, Masters in Modern Human Anatomy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butterfly handheld ultrasound machine in people with Ultrasound and Education, run by University of Colorado, Denver 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 2 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 31 Jan 2024. 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?
Comparison of participant assesment scores when asked to identify key features of the FAST and Carpal Tunnel between in person learners and virtual learners. (time frame: 10 minutes). 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 NCT05013476, which also lists 3 linked publications.
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 31 Jan 2024.