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

NCT06055400 | Completed DMC

• 1 other identifier: CGMH AR
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Cognitive load; Clinical competence; Augmented reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cognitive load of CVC placement

  up to 30 minutes

Study Arms (2)

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.

Device: AR-US

Interventions

AR-US DEVICE

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

Also known as: augmented reality smart glasses

AR-US

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shu-Chen Liao: lead

Study Sites (1)

Keelung Chang Gung Memorial Hospita

Keelung, Guishan Dist., 204, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 39334275 DERIVED

Study Officials

• Shu-Chen Liao, M.D.

  Department of Emergency Medicine, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of simulation center, Principal Investigator, Clinical Associate Professor.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 26, 2023
• Study Start: August 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

TW (1)