Clincosm LogoSign in Get a demo

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

Sponsor
Shu-Chen Liao (Other)
Overall Status
Completed
CT.gov ID
NCT06055400
Collaborator
(none)
47
Enrollment
1
Location
2
Arms
17
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: AR-US
 N/A

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

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Ultrasound-guided Interventions With Augmented Reality Visualization: A Randomized Crossover Study Investigating Trainees' Performance and Cognitive Load During Skill Acquisition
Actual Study Start Date :
Aug 1, 2021
Actual Primary Completion Date :
Dec 31, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Performance of CVC Placement [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.

    Secondary Outcome Measures

    1. Cognitive load of CVC placement [up to 30 minutes]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Keelung Chang Gung Memorial Hospita Keelung Guishan Dist. Taiwan 204

    Sponsors and Collaborators

    • Shu-Chen Liao

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shu-Chen Liao, Director of simulation center, Principal Investigator, Clinical Associate Professor., Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT06055400
    Other Study ID Numbers:
    • CGMH AR
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shu-Chen Liao, Director of simulation center, Principal Investigator, Clinical Associate Professor., Chang Gung Memorial Hospital
    Cognitive load
    Clinical competence
    Augmented reality

    Study Results

    No Results Posted as of Sep 26, 2023