Virtual Reality Training for ECMO Circuit Checks

NCT07138599 | Completed

• 2 other identifiers: MEC-2023-0666LUMC Fellowship Grant 2023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

ECMO; Virtual Reality; Simulation; Medical Education; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Number of Missed Items During the ECMO Circuit Check

  For every participant, the eleven mandatory steps will be scored as correct or incorrect by an independent assessors who are masked to training allocation and who review the video recording of the live assessment. The total count of items marked incorrect will be recorded for each participant. The mean number of missed items in each study arm will be used as the analytic metric. Lower counts indicate better performance.

  Assessment performed immediately after the conclusion of the VR or conventional training.

• Time Needed to Complete the Eleven Step ECMO Circuit Check

  For every participant, the interval in seconds from first contact with the circuit to verbal declaration of completion will be measured and verified against the video timestamp by the independent assessors who are masked to training allocation. The mean completion time in seconds will be compared between study arms. Shorter times indicate better performance.

  Assessment performed immediately after the conclusion of the VR or conventional training.

Secondary Outcomes (3)

• Proportion of Participants Requiring Assistance During the Circuit Check

  Assessment performed immediately after the conclusion of the VR or conventional training.

• VR Simulator Face Validity Score (USE Questionnaire Total)

  Questionnaire filled in immediately after the completion of the VR simulation.

• Simulator Content Validity Index

  Questionnaire filled in by expert cohort immediately after the completion of the VR simulation.

Study Arms (3)

Conventional EMCO Circuit Check Training

ACTIVE COMPARATOR

Participants allocated to the conventional video training arm will view a narrated video recording in which two certified perfusionists give a standard educational talk and demonstration that they provide when educating new intensive care unit staff and perfusionists-in-training. The identical eleven step circuit check on a primed wet circuit matches the equipment used for outcome assessment. The video will be presented on a laptop with headphones in a quiet room with minimal distractors, after which learners may asks questions or clarification from the study coordinator prior to the beginning of the assessment.

Other: Instructional Video of Certified Perfusionists on Performing a Circuit Check

Virtual Reality ECMO Circuit Check Simulation Training Novice Group

EXPERIMENTAL

Novice participants assigned to the Virtual Reality Simulation arm will undergo a fifteen minute individual session delivered on a Meta Quest 3 headset that simulates a fully interactive extracorporeal membrane oxygenation circuit. The scenario will guide each learner through the eleven prescribed safety checks while allowing manipulation of circuit components and providing immediate audio visual feedback. No further instruction will precede the subsequent live assessment. This arm then undergoes the physical assessment on a physical ECMO practice circuit.

Device: Virtual Reality ECMO Simulation Training

Experimental: Virtual Reality ECMO Circuit Check Simulation Training Expert Group

OTHER

Expert participants assigned to the Virtual Reality Simulation arm will undergo a fifteen minute individual session delivered on a Meta Quest 3 headset that simulates a fully interactive extracorporeal membrane oxygenation circuit. The scenario will guide each learner through the eleven prescribed safety checks while allowing manipulation of circuit components and providing immediate audio visual feedback. This arm is then asked to complete a questionnaire regarding the relevance of each of the steps in the circuit check to investigate the content validity. Participants then fill out a USE questionnaire with the purpose of demonstrating face validity.

Device: Virtual Reality ECMO Simulation Training

Interventions

Virtual Reality ECMO Simulation Training DEVICE

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.

Also known as: VR ECMO-sim, Virtual Reality Extracorporeal Membrane Oxygenator

Experimental: Virtual Reality ECMO Circuit Check Simulation Training Expert Group; Virtual Reality ECMO Circuit Check Simulation Training Novice Group

Instructional Video of Certified Perfusionists on Performing a Circuit Check OTHER

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.

Also known as: Conventional Training

Conventional EMCO Circuit Check Training

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Erasmus Medical Center: collaborator

Study Sites (2)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

Location

Erasmus MC University Hospital

Rotterdam, 3015GD, Netherlands

Location

Related Publications (4)

• Mahtab EAF, Max SA, Braun J, Regeer MV, Kaufman B, Dunning J, Bibleraaj B, Andreas M, Rodriguez Lecoq R, Klinceva M, Rosalia R, Lorusso R, Bruining N, Egorova AD. Developing a Systematic Approach for the Implementation of Medical Extended Reality Learning Modules in Cardiothoracic Health Care: Recommendations From an International Expert Group. JACC Adv. 2025 Feb 26;4(3):101633. doi: 10.1016/j.jacadv.2025.101633. Online ahead of print.

  PMID: 40147055 BACKGROUND

• Sadeghi AH, Peek JJ, Max SA, Smit LL, Martina BG, Rosalia RA, Bakhuis W, Bogers AJ, Mahtab EA. Virtual Reality Simulation Training for Cardiopulmonary Resuscitation After Cardiac Surgery: Face and Content Validity Study. JMIR Serious Games. 2022 Mar 2;10(1):e30456. doi: 10.2196/30456.

  PMID: 35234652 BACKGROUND

• Peek JJ, Max SA, Bakhuis W, Huig IC, Rosalia RA, Sadeghi AH, Mahtab EAF. Virtual Reality Simulator versus Conventional Advanced Life Support Training for Cardiopulmonary Resuscitation Post-Cardiac Surgery: A Randomized Controlled Trial. J Cardiovasc Dev Dis. 2023 Feb 4;10(2):67. doi: 10.3390/jcdd10020067.

  PMID: 36826563 BACKGROUND

• Babar ZUD, Max SA, Martina BG, Rosalia RA, Peek JJ, van Dijk A, Sadeghi AH, Mahtab EAF. Virtual reality simulation as a training tool for perfusionists in extracorporeal circulation: Establishing face and content validity. JTCVS Tech. 2023 Jun 20;21:135-148. doi: 10.1016/j.xjtc.2023.06.004. eCollection 2023 Oct.

  PMID: 37854847 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiothoracic Surgeon & PI

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 24, 2025
• Study Start: January 29, 2024
• Primary Completion: November 5, 2024
• Study Completion: December 5, 2024
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be hosted for a minimum of 20 years through the Zenodo platform.
• Access Criteria: A DOI link will be made available in the publication to the data, and requests to access the data can be made through the Zenodo platform.

Locations

NL (2)