Virtual Reality Training for ECMO Circuit Checks

This investigation will be a prospective multicentre study that integrates a preparatory validation phase with a concealed-allocation randomised controlled trial. Its central purpose will be to determine whether an immersive virtual reality module can reproduce the realism of a wet laboratory and transfer measurable skill to novices who must perform an eleven-step extracorporeal membrane oxygenation circuit check. The clinical need for scalable, high-fidelity training, together with encouraging early feasibility work in related simulators, provides the scientific rationale for this protocol . Two Dutch university hospitals will serve as recruiting sites. In phase one eight consultant intensivists or senior perfusionists with at least five years of extracorporeal experience will complete a single scenario inside the Virtual-Reality Extracorporeal Membrane Oxygenation Simulator and will then answer the nineteen-item Usefulness Satisfaction and Ease-of-Use questionnaire. Their judgments will supply evidence for face and content validity according to the Messick framework. Phase two will enrol forty-four intensive-care or cardiothoracic nurses who have never operated the Cardiohelp platform. A computer-generated list prepared with Research Randomizer will assign them in a one-to-one ratio either to a VR training session, or to a seven minute narrated training video that mirrors conventional bedside teaching. Allocation will be concealed by an automated Microsoft Forms workflow so that trainers cannot foresee the next assignment; video assessors who will later rate performance will remain masked to group allocation. The virtual reality module will be delivered on stand-alone Meta Quest headsets, with a simulation produced with Unreal Engine. The control video will be shown on a laptop with headphones and will depict licensed perfusionists demonstrating the identical checklist in real time, after which learners may ask questions from the coordinator, who will answer them using the physical ECMO circuit that is present. Immediately after their assigned training every novice will complete an physical circuit check on a primed wet circuit with a Cardiohelp console. This assessment is filmed and later assessed by an examiner, blinded to allocation, who will score the procedure from video using an eleven-item checklist validated by the expert panel and will record total completion time. The assessment encounter itself will constitute an external criterion that will permit concurrent validity testing . All questionnaire data will be captured through encrypted Microsoft Forms and stored in SharePoint, where automatic linkage to study identifiers will occur. Raw video files will be retained on a secure institutional drive with mirrored backup in SharePoint. After database lock, a de-identified archive will be created and preserved for ten years under Erasmus MC and Leiden UMC governance . Power analysis based on a projected mean difference of 1 checklist error and a standard deviation of 1.1 showed that 16 novices per arm will provide at least eighty percent power at the 5% significance level; the same computation justified recruiting eight experts for the validation phase . Primary analyses will follow an intention-to-treat principle. Continuous variables will first undergo Shapiro-Wilk testing; normally distributed outcomes will be compared with independent samples t tests, whereas non-normal data will use the Mann-Whitney U statistic. Categorical data will be analysed with Chi squared or Fisher exact tests as appropriate. Confounding will be explored with analysis of covariance when indicated, and significance will be declared at p\<0.05. Quality assurance will rest on several safeguards. Assessors will complete calibration sessions before scoring begins, database logic checks in Microsoft Forms will limit data entry errors, and the coordinating centres will perform audits of consent forms, randomisation logs and source videos against electronic records. Risks are considered minimal. A small proportion of participants may experience transient nausea while wearing the headset, but symptoms usually resolve promptly once the display is removed; no other adverse effects are foreseen . The study will adhere to the Declaration of Helsinki and GDPR legislation. Written informed consent will be obtained from every participant, and ethical approval has already been granted by the boards of both participating centres. Upon completion, the anonymised dataset and accompanying data dictionary will be deposited in Zenodo, enabling independent verification and secondary analyses By pairing validity evidence with an assessor-blinded randomised comparison, this protocol will clarify whether an inexpensive head-mounted display can deliver training that is realistic, comprehensive and transferable to the bedside, setting a template for future immersive-simulation research in extracorporeal membrane oxygenator support.