Virtual Reality Training for ECMO Circuit Checks

Summary

Purpose of the Study:

This investigation will examine whether a brief session with an immersive virtual-reality headset can prepare critical-care nurses to carry out an eleven-step extracorporeal membrane oxygenation circuit check as accurately and as quickly as the standard narrated training video that clinicians normally watch at the bedside.

Who Will Take Part:

Two groups of volunteers will be enrolled. Eight senior clinicians who already have at least five years of extracorporeal membrane oxygenator experience will test the simulator so that investigators can confirm its realism and educational relevance. In a separate arm, forty-four intensive-care or cardiothoracic nurses with no prior ECMO training or ECMO patient care experience.

How Participants Will Be Assigned:

Nurses will be allocated by computer in a one-to-one ratio either to the virtual-reality session or to the video. Because the assignment sequence will be generated in advance and concealed inside a secure web form, neither facilitators nor learners will be able to predict the next allocation. The two examiners who will judge each live circuit check will not be told which training each nurse received.

What Will Happen During the Study:

Experts will first complete a single virtual-reality scenario that guides them through the eleven checks on a simulated circuit. Immediately afterward they will rate the experience with the standard Usefulness Satisfaction and Ease-of-Use questionnaire.

Nurses will then receive their assigned training. The virtual-reality group will spend fifteen minutes practising the checklist inside a standalone headset, while the video group will watch a seven-minute narrated recording that mirrors the usual bedside demonstration.

After training every nurse will complete a real circuit check on a primed wet circuit. A blinded examiner will watch the procedure, score each of the eleven checklist items, and time the task from start to finish.

Measurements the Researchers Will Use:

For nurses the primary measurements will be the number of checklist items missed and the total time needed to finish the procedure. For experts the main measurements will be their ratings of realism, usefulness, and ease of use. Investigators will also explore the link between the kind of training received and performance during the wet-lab task to confirm whether the simulator provides valid learning.

Where and For How Long the Study Will Run The investigation will take place at two university medical centres in the Netherlands. Each participant's involvement will last no longer than one day, and the entire study is expected to be completed within twelve months of first enrolment.

How Many People Will Take Part and Why:

Statistical calculations show that twenty-two nurses in each arm will give more than eighty-five per cent power to detect one missed checklist item between groups when the type-one error rate is five per cent. Allowing for potential withdrawals, forty-four novices and eight experts will be recruited.

Why the Study Design Matters:

By combining an expert validation phase with a randomised, assessor-blinded trial in novices, the study will determine both the realism of the virtual-reality simulator and its ability to improve real-world performance.

Conditions

• ECMO
• Training Effectiveness
• Education Nursing
• Educational Intervention
• Virtual Reality
• Simulation Based Medical Education
• Simulation Training

Interventions

DEVICE

Virtual Reality ECMO Simulation Training

The intervention is a virtual reality simulation of an ECMO system, whereby the user is guided through the steps of how to perform an 11 step ECMO circuit check, and specific indicators of abnormal functioning are highlighted. The simulation is produced in Unreal Engine 4.23, and it simulates a virtual ICU and a virtual patient.

OTHER

Instructional Video of Certified Perfusionists on Performing a Circuit Check

This intervention is a seven minute narrated high definition video in which a two certified perfusionist describe how to perform the identical eleven step circuit check on a primed Cardiohelp circuit, what to look for in terms of pathology or abnormal function, and . Participants will view the clip once on a laptop with headphones in a quiet room and may ask questions or receive clarification from the study coordinator, and this will be demonstrated on the physical ECMO machine and/or circuit present. The video conveys the checklist at reduced speed and explaining the purpose of each step and has been reviewed by the expert panel for accuracy and completeness.

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• Leiden University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-29

Primary Completion

2024-11-05

Completion

2024-12-05

Countries

• Netherlands

Study Locations