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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06055400
• Other study ID #: CGMH AR
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• AR-US
The ultrasound imagery is projected onto the glasses, and participants use the AR-US throughout the entire CVC placement procedure

Locations

Country	Name	City	State
Taiwan	Keelung Chang Gung Memorial Hospita	Keelung	Guishan Dist.

Sponsors (1)

Lead Sponsor	Collaborator
Shu-Chen Liao

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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