Validation and clinical use of the Maquet (Getinge) original series Rotaflow extracorporeal membrane oxygenation device in hyperbaric conditions: a technical report.

INTRODUCTION

Extracorporeal membrane oxygenation (ECMO) has not been previously used clinically in the modern hyperbaric chamber. We describe the modifications, validation and clinical performance of the Maquet (Getinge) original series Rotaflow (Rotaflow 1), Quadrox-i adult microporous membrane oxygenator and permanent life support (PLS) circuit under hyperbaric conditions.

METHODS

A Rotaflow 1 and Quadrox oxygenator underwent power supply modifications and rigorous safety testing in the hyperbaric environment using a PLS circuit primed with normal saline. Clinical validation was subsequently undertaken during a 'last resort' course of 13 hyperbaric oxygen treatment (HBOT) sessions for a patient suffering a life threatening vaso-invasive fungal infection requiring support with venovenous ECMO.

RESULTS

Preliminary testing and subsequent clinical application in the hyperbaric chamber demonstrated steady flow through the circuit based on pump revolutions per minute, with up to 180 mL (10%) variability demonstrated between the console display compared to the independent flow meter. No significant changes to flow variability were noted during pressurisation and decompression phases. Device temperature remained within safe limits. No bubbles were visually or sonographically detected. There were no performance or integrity issues detected through compression, maintenance and decompression phases. During clinical use, the patient remained stable and hyperoxygenation targets were achieved. Membrane oxygenator oxygen inflow set at up to 8 L·min-1 maintained CO2 clearance.

CONCLUSIONS

After safety related modifications to the console's power supply, the Rotaflow 1 console, Quadrox oxygenator and PLS circuit performed satisfactorily up to 243 kPa during repeated clinical use.