An Investigation of Trainees' Performance in Augmented Reality Simulation for Invasive Procedure Training

Study Overview
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Brief Summary
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The primary aim of this study is to measure the efficacy of augmented reality technology in ultrasound-guided medical intervention.

Detailed Description
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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..

Official Title
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Ultrasound-guided Interventions With Augmented Reality Visualization: A Randomized Crossover Study Investigating Trainees' Performance and Cognitive Load During Skill Acquisition

Conditions
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Healthy

Intervention / Treatment
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* Device: AR-US


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard US<br>The participants underwent CVC placement using standard ultrasound guidance. | |
| Experimental: AR-US<br>The participants underwent CVC placement using AR-HMD ultrasound guidance. | Device: AR-US<br>* The ultrasound imagery is projected onto the glasses, and participants use the AR-US throughout the entire CVC placement procedure<br>* Other names: augmented reality smart glasses;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive load, Clinical competence, Augmented reality