HealthyNCT06055400
An Investigation of Trainees' Performance in Augmented Reality Simulation for Invasive Procedure Training
A study testing AR-US in people with Healthy, run by Shu-Chen Liao at 1 site in Taiwan.
Trial summary
The primary aim of this study is to measure the efficacy of augmented reality technology in ultrasound-guided medical intervention. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AR-US
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 20 years
- Final-year medical students (UGY)
- Post-year graduate physicians (PGY)
- Physicians who have previously received training in ultrasound-guided CVC placement or who have experience with such procedures.
Who cannot join
- Participants who experience discomfort during the process, are pregnant, have high blood pressure, have experienced recent dizziness, have inner ear diseases, suffer from claustrophobia, have undergone recent surgery, have visual impairment, have heart disease, have epilepsy, or refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Interventions With Augmented Reality Visualization: A Randomized Crossover Study Investigating Trainees' Performance and Cognitive Load During Skill Acquisition
The primary aim of this study is to measure the efficacy of augmented reality technology in ultrasound-guided medical intervention.
Read the detailed description
BACKGROUND: A significant challenge facing novice physicians is mastering ultrasound(US)-guided procedures, such as central venous catheter (CVC) placement. CVC placements are typically performed on critically ill patients and demand precision and speed. Physicians are often required to switch focus between the ultrasound screen and the patient, memorize multiple images, coordinate hand-eye movements, and interpret 2D images in a 3D context simultaneously. These complexities pose challenges in spatial orientation and impose a considerable cognitive load, affecting both learning and performance. Within the pedagogical landscape, medical educators are exploring the potential merits of Augmented Reality (AR) via head-mounted displays to enhance immersive learning experiences in clinical settings. This study aimed to determine whether AR could ease challenges related to spatial orientation and cognitive overload during this procedure and ultimately enhance skill acquisition for trainees.
Intervention:
Prior to the commencement of the trial, all participants verified their previous training in ultrasound-guided CVC placement. They also provided their written informed consent. The participants are set to be split into two groups as part of a crossover design: the first group will initially be subjected to the traditional ultrasound-guided CVC placement, whereas the second group will begin with the AR-assisted CVC placement
STUDY IMPLICATIONS:
Leveraging AR technology in skill acquisition may reduce trainees' cognitive burden and improve trainee efficiency during ultrasound-guided CVC placement procedures..
- Conditions
- Healthy
- Being tested
- AR-US
- Keywords
- Cognitive load, Clinical competence, Augmented reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-USDevice
Also called augmented reality smart glasses
The ultrasound imagery is projected onto the glasses, and participants use the AR-US throughout the entire CVC placement procedure
| Study group | Role | What they receive |
|---|---|---|
| standard US | No intervention | The participants underwent CVC placement using standard ultrasound guidance. |
| AR-US | Experimental | The participants underwent CVC placement using AR-HMD ultrasound guidance. Receives: Device: AR-US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of CVC Placement
first pass rate in percent, success/failure rate in percent, number of attempts, number of artery punctures, the number of operator head turns in counts, venous access time (from start to venous access in seconds), lag time (from access ultrasound probe to venous access in seconds), catheterization time (from start to complete catheterization in seconds), total time in seconds.
Measured: up to 30 minutes
Secondary outcomes (1)
Cognitive load of CVC placement
Cognitive load of CVC placement measured in NASA Task Load Index. The score of the NASA task load index ranges from 0 to 20. A higher score indicates a higher cognitive load.
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shu-Chen Liao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shu-Chen Liao, Chang Gung Memorial Hospital
- Investigators
- Shu-Chen Liao, M.D., Principal investigator, Department of Emergency Medicine, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055400
- Sponsor's protocol ID
- CGMH AR
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liao SC, Shao SC, Gao SY, Lai EC. Augmented reality visualization for ultrasound-guided interventions: a pilot randomized crossover trial to assess trainee performance and cognitive load. BMC Med Educ. 2024 Sep 27;24(1):1058. doi: 10.1186/s12909-024-05998-8.
PubMed 39334275
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Interventions With Augmented Reality Visualization: A Randomized Crossover Study Investigating Trainees' Performance and Cognitive Load During Skill Acquisition
- ClinicalTrials.gov ID
- NCT06055400
- Acronym / sponsor ID
- CGMH AR
- Conditions
- Healthy
- Keywords
- Cognitive load, Clinical competence, Augmented reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Shu-Chen LiaoUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Sep 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.
The primary aim of this study is to measure the efficacy of augmented reality technology in ultrasound-guided medical intervention.
Detailed description
BACKGROUND: A significant challenge facing novice physicians is mastering ultrasound(US)-guided procedures, such as central venous catheter (CVC) placement. CVC placements are typically performed on critically ill patients and demand precision and speed. Physicians are often required to switch focus between the ultrasound screen and the patient, memorize multiple images, coordinate hand-eye movements, and interpret 2D images in a 3D context simultaneously. These complexities pose challenges in spatial orientation and impose a considerable cognitive load, affecting both learning and performance. Within the pedagogical landscape, medical educators are exploring the potential merits of Augmented Reality (AR) via head-mounted displays to enhance immersive learning experiences in clinical settings. This study aimed to determine whether AR could ease challenges related to spatial orientation and cognitive overload during this procedure and ultimately enhance skill acquisition for trainees.
Intervention:
Prior to the commencement of the trial, all participants verified their previous training in ultrasound-guided CVC placement. They also provided their written informed consent. The participants are set to be split into two groups as part of a crossover design: the first group will initially be subjected to the traditional ultrasound-guided CVC placement, whereas the second group will begin with the AR-assisted CVC placement
STUDY IMPLICATIONS:
Leveraging AR technology in skill acquisition may reduce trainees' cognitive burden and improve trainee efficiency during ultrasound-guided CVC placement procedures..
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard US | No intervention | –The participants underwent CVC placement using standard ultrasound guidance. |
| AR-US | Experimental | Device: AR-USThe participants underwent CVC placement using AR-HMD ultrasound guidance. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 20 years
- Final-year medical students (UGY)
- Post-year graduate physicians (PGY)
- Physicians who have previously received training in ultrasound-guided CVC placement or who have experience with such procedures.
Key exclusion criteria (1 listed)
- Participants who experience discomfort during the process, are pregnant, have high blood pressure, have experienced recent dizziness, have inner ear diseases, suffer from claustrophobia, have undergone recent surgery, have visual impairment, have heart disease, have epilepsy, or refuse to participate.
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 |
|---|---|---|
| AR-USAlso: augmented reality smart glassesThe ultrasound imagery is projected onto the glasses, and participants use the AR-US throughout the entire CVC placement procedure | Device | AR-US |
Primary outcome
Performance of CVC Placement
Time frame: up to 30 minutes
first pass rate in percent, success/failure rate in percent, number of attempts, number of artery punctures, the number of operator head turns in counts, venous access time (from start to venous access in seconds), lag time (from access ultrasound probe to venous access in seconds), catheterization time (from start to complete catheterization in seconds), total time in seconds.
1 secondary outcome
Cognitive load of CVC placement
Time frame: up to 30 minutes
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 26 Sep 2023.
- Derived from this study: PubMed 39334275Liao SC, Shao SC, Gao SY, Lai EC. Augmented reality visualization for ultrasound-guided interventions: a pilot randomized crossover trial to assess trainee performance and cognitive load. BMC Med Educ. 2024 Sep 27;24(1):1058. doi: 10.1186/s12909-024-05998-8.
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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.
Shu-Chen Liao, M.D. principal investigator
Department of Emergency Medicine, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR-US in people with Healthy, run by Shu-Chen Liao at 1 site in Taiwan.
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 1 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 26 Sep 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 Taiwan. 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?
Performance of CVC Placement (time frame: up to 30 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 NCT06055400, which also lists 1 linked publication.
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 26 Sep 2023.