Clinical trial NCT06055400: An Investigation of Trainees' Performance in Augmented Reality Simulation for Invasive Procedure Training
Official title: Ultrasound-guided Interventions With Augmented Reality Visualization: A Randomized Crossover Study Investigating Trainees' Performance and Cognitive Load During Skill Acquisition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Cognitive load
Clinical competence
Augmented reality
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

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..

Eligibility criteria: 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.

Primary outcomes:
measure: Performance of CVC Placement
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Cognitive load of CVC placement
timeFrame: up to 30 minutes
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospita
state: Guishan Dist.
Study officials:
affiliation: Department of Emergency Medicine, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.
name: Shu-Chen Liao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: