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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: AR-US

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Guishan Dist.
    • Keelung, Guishan Dist., Taiwan, 204
      • Keelung Chang Gung Memorial Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

1. Age greater than or equal to 20 years
2. Final-year medical students (UGY)
3. Post-year graduate physicians (PGY)
4. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shu-Chen Liao
• Investigators: Principal Investigator: Shu-Chen Liao, M.D., Department of Emergency Medicine, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Augmented reality; Cognitive load; Clinical competence
• Other Study ID Numbers: CGMH AR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No