Full article available here.
Validation and clinical use of the Maquet (Getinge) original series Rotaflow extracorporeal membrane oxygenation device in hyperbaric conditions: a technical report
Theo Tsouras1, Bridget Devaney1,2,3, Zhiliang Caleb Lin1,2,3, Christopher Covelli4, Lloyd Roberts1,3, Vinodh Bhagyalakshmi Nanjayya1,3, Ian Millar1,3
1 Department of Intensive Care and Hyperbaric Medicine, Alfred Health, Melbourne, Australia
2 Emergency and Trauma Centre, Alfred Health, Melbourne, Australia
3 School of Public Health and Preventative Medicine, Monash University, Melbourne, Australia
4 Monash University, Melbourne, Australia
Corresponding author: Dr Bridget Devaney, Department of Intensive Care and Hyperbaric Medicine, Alfred Health, 55 Commercial Road, Melbourne, VIC 3004, Australia
ORCiD: 0000-0001-6521-418X
Keywords
ECMO; Equipment; Hyperbaric oxygen treatment; Intensive care; Life support; Medical devices; Perfusion
Abstract
(Tsouras T, Devaney B, Lin ZC, Covelli C, Roberts L, Nanjayya VB, Millar I. Validation and clinical use of the Maquet (Getinge) original series Rotaflow extracorporeal membrane oxygenation device in hyperbaric conditions: a technical report. Diving and Hyperbaric Medicine. 2025 December 20;55(4):323−329. doi: 10.28920/dhm55.4.323-329. PMID: 41364855.)
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 veno-venous 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.
Copyright: This article is the copyright of the authors who grant Diving and Hyperbaric Medicine a non-exclusive licence to publish the article in electronic and other forms.