Mixed-reality REBOA Simulator With Virtual Coaching

NCT05062928 | Completed

• 1 other identifier: IRB202101271
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a life-saving emergency procedure that is highly suited for simulation-based training. This study aims to assess the validity of our REBOA simulator with virtual coach (or live quantitative feedback) for mastery learning. The hypotheses are: H0: Virtual coach is non-inferior in REBOA training to an average human instructor. H1: Virtual coach is inferior in REBOA training to an average human instructor. We expect to learn whether the virtual coach is non-inferior to an average human instructor for US-guided REBOA training. Additionally, we expect to find which determinants affect success rate most and to assess the needs for the current simulator system's future software development.

Conditions

Hemorrhage; Simulation Training

Keywords

aorta, abdominal; aorta, thoracic; Teaching

Outcome Measures

Primary Outcomes (1)

• Virtual coach is non-inferior in REBOA training to an average human instructor

  The study will compare the virtual coach group and human instructor groups by means of reaching to mastery. Mastery is defined as two consecutive successful REBOA insertion to zone 1 and zone 2. The investigators defined the success criteria in the methods section in detail.

  2 hours

Secondary Outcomes (3)

• Define the time required for a complete REBOA insertion on a simulator

  2 minutes

• Define the time required the time to mastery

  2 hours

• Association of success rates and complications on the simulator to spatial ability

  8 minutes

Study Arms (2)

Virtual coaching group

EXPERIMENTAL

In this group, the virtual coach will train and assess.

Other: Virtual coach

Human instructor group

NO INTERVENTION

In this group, a human instructor will train, but the virtual coach will assess.

Interventions

Virtual coach OTHER

This group will be trained and assessed by the virtual coach.

Virtual coaching group

Eligibility Criteria

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

You may qualify if:

• \>18 years of age

You may not qualify if:

• i. not obtaining informed consent,
• ii. inability to complete all the procedures,
• iii. Completed a REBOA course iv. Used the US-guided REBOA simulator in any way

Sponsors & Collaborators

• University of Florida: lead
• Madigan Army Medical Center: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32601, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samsun Lampotang

  Univeristy of Florida

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: February 10, 2022
• Primary Completion: April 11, 2022
• Study Completion: November 11, 2022
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (1)