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OpenTrials
Completed

NCT Number: NCT06055400

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

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

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keelung Chang Gung Memorial Hospita

Keelung, Guishan Dist., 204, Taiwan

About this study

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..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AR-US

Device

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

Primary outcomes

  1. Performance of CVC Placement

    Time frame: 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 outcomes

  1. Cognitive load of CVC placement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shu-Chen Liao

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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