Colloquia

Summary

Extracorporeal Membrane Oxygenation (ECMO) is a therapy for patients with severe respiratory or cardiac failure. ECMO acts as an artificial lung or heart-lung support system. The ECMO device drains blood from the body, facilitates gas exchange via an oxygenator, and returns the oxygenated blood to the patient. ECMO is often used as a bridge to transplant or recovery.

Active ECMO protocols enable patients to remain awake and engaged during treatment, which has been associated with improved outcomes. Ambulatory ECMO allows critically ill patients to walk while being on ECMO to improve the physical condition and prevent neuromuscular weakness. However, implementation of ambulatory ECMO is complex and requires a multidisciplinary team for patient assistance and equipment management. Additionally, there is no solution for stabilizing the cannula during mobilization.

Van Galen et al. developed an innovative device for ambulatory Veno-Venous (V-V) ECMO patients, the ECMOve version 1 (ECMOve V1) . This walking support system facilitates safe ambulation while accommodating all necessary V-V  ECMO equipment for both stationary and ambulatory use. ECMOve prevents stress and strain on the cannula and requires only two caregivers for its operation.

This project aims to optimize several core components of  ECMOve V1 including the extendable walking frame, seat, and backrest. Additionally, an adjustable IV stand, an adjustable pushing handle, a gas tank holder, and safety brakes were implemented. Verification testing was performed following relevant ISO standards. User requirements were evaluated by physiotherapists and medical doctors in the Medisch Spectrum Twente (MST) hospital as a stepping stone to clinical validation testing in a specialized ECMO environment.

Verification testing shows that ECMOve V2 meets relevant ISO standards for mechanical strength and stability. Moreover, design requirements including ergonomics, ease of cleaning, and forces necessary for optimal device manoeuvrability are met. Pre-liminary validation highlights the importance of tailored ISO standards for ambulatory V-V ECMO, integration of mechanical ventilation and vital monitoring, and the opportunity for system customization between various clinics. In conclusion, ECMOve V2 is advancing towards Technology Readiness Level (TRL) 5, making the device suitable for validation testing in a clinical ECMO environment.