Training Healthcare Professionals in an Artificial Intelligence Based Virtual Reality Extracorporeal Membrane Oxygenation Simulator Versus Conventional Video Training; a Multicentre Feasibility Study and Randomised Controlled Trial
Trial ID: NCT07138599
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-01-29
Completion date: 2024-12-05
Sponsor: Leiden University Medical Center
Collaborators: Erasmus Medical Center
Conditions: ECMO; Training Effectiveness; Education Nursing; Educational Intervention; Virtual Reality; Simulation Based Medical Education; Simulation Training
Interventions: Virtual Reality ECMO Simulation Training; Instructional Video of Certified Perfusionists on Performing a Circuit Check
Locations: Leiden University Medical Center; Erasmus MC University Hospital
Countries: Netherlands; Netherlands
Enrollment: 42
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
Expert Cohort

Inclusion Criteria:

I. Licensed consultant intensivist or certified clinical perfusionist with ≥ 5 years ECMO experience II. Currently employed at one of the participating centres III. Provides written informed consent

Exclusion Criteria:

I. History of severe motion-sickness, vertigo, seizure disorder, or uncorrected visual/vestibular impairment that precludes safe VR use

Novice Cohort

Inclusion Criteria:

I. Registered ICU or cardiothoracic-surgery nurse with no experience with the Cardiohelp ECMO system II. Age ≥ 18 years III. Able to understand written and spoken Dutch IV. Provides written informed consent

Exclusion Criteria:

I. Any formal Cardiohelp ECMO course, wet-lab, or VR ECMO session completed before enrolment II. As per experts: severe motion-sickness, seizure disorder, uncorrected visual/vestibular impairment

Outcomes:
Number of Missed Items During the ECMO Circuit Check; Time Needed to Complete the Eleven Step ECMO Circuit Check