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ECMOve - A device to support patient mobilization on ECMO : Optimization, verification, and testing by stakeholders.

Hulshof, Simon (2024) ECMOve - A device to support patient mobilization on ECMO : Optimization, verification, and testing by stakeholders.

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Abstract:Ambulatory Extracorporeal Membrane Oxygenation (ECMO) allows critically ill patients to mobilize, aiding recovery and preventing neuromuscular weakness. However, its implementation is complex and requires a multidisciplinary team for equipment management and patient assistance. Additionally, there is no solution for stabilizing the cannula during mobilization. Van Galen et al. [5] developed an innova-tive device for ambulatory Veno-Venous (V-V) ECMO patients, the ECMOve version 1 (ECMOve V1). This walking support system is designed to facilitate safe ambulation while accommodating all neces-sary V-V ECMO equipment for both stationary and ambulatory use. ECMOve prevents stress and strain on the cannula and is engineered in a way that only two caregivers are required for its operation. Building on the basic functionalities demonstrated by ECMOve V1 (proof of concept), this work aimed to opti-mize several core components of ECMOve V1 to meet key user-and design requirements. This work focused on optimizing the extendable walking frame, seat, and backrest. Additionally, the incorporation of an adjustable intravenous (IV) stand, an adjustable pushing handle, a gas tank holder, and safety brakes were implemented. Verification procedures, carried out in alignment with relevant ISO standards and design requirements, alongside testing by stakeholders at Medisch Spectrum Twente (MST), have advanced ECMOve V2 from TRL 3 to TRL 4. Verification of ECMOve V2 confirmed that the device meets most ISO standards for strength and stability, along with design requirements including ergonom-ics, ease of cleaning, and manoeuverability. Stakeholder tests at MST highlighted the importance of tailored ISO standards for V-V ECMO patients, addition of mechanical ventilation and vital monitoring, and suggested the development of multiple ECMOve versions aligned with particular needs of various clinics. To conclude, ECMOve V2 is advancing towards achieving Technology Readiness Level (TRL) 5, with ongoing development aimed at preparing the device for clinical testing in specialized (ambula-tory) V-V ECMO environments. Keywords: Ambulatory ECMO; Veno-Venous (V-V); ECMOve V1; Device optimization; Design re-quirements (DRS); User requirements (URS); Verification; ISO standards; Testing by stakeholders; ECMOve V2; Technology Readiness Level (TRL)
Item Type:Essay (Master)
Faculty:ET: Engineering Technology
Subject:01 general works
Programme:Mechanical Engineering MSc (60439)
Link to this item:https://purl.utwente.nl/essays/104637
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