Costs of venovenous extracorporeal membrane oxygenation (VV-ECMO) and its potential contribution to quality-adjusted life years: a mixed-methods study protocol.

Abstract

<h4>Background</h4>Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a mechanical life support modality used in patients with severe respiratory failure. Despite rising case numbers worldwide, costs are substantial, while patient-centered outcomes, particularly survival and quality-adjusted life years (QALYs), remain uncertain. High complication and mortality rates also persist. Limited financial budgets, human resources, and treatment capacities in healthcare systems require critical evaluation of whether continued use of this resource-intensive intervention at the current scale is sustainable and ethically justifiable. This study aims to provide further insight into this issue and to support healthcare decision-making by offering a structured economic and ethical framework for evaluating VV-ECMO, particularly regarding resource allocation, proportionality of costs, and the justification of its use in high-cost intensive care.<h4>Methods</h4>This mixed-methods study consists of two parts. Part A includes two systematic literature reviews. The first examines total and daily in-hospital costs per patient, as well as outcomes measured in QALYs for adult patients supported with VV-ECMO across multiple countries between 2005 and 2024. The second aim is to identify established interventions with confirmed QALY gain that can subsequently be used as comparators for VV-ECMO. Part B evaluates the results according to the principles of medical ethics: beneficence, non-maleficence, autonomy, and justice.<h4>Discussion</h4>Given limited financial, personnel, and treatment capacities in healthcare systems, the question of how highly resource-intensive interventions such as VV-ECMO can be justified has increasing clinical, economic, and ethical relevance. By linking cost-related outcomes with a structured ethical evaluation, this study aims to contribute to a more differentiated discussion of whether and under which conditions VV-ECMO may be considered proportionate and justifiable within resource-constrained healthcare settings. Expected challenges include data availability and quality, differences in reported charges versus costs, and variation in healthcare systems, reimbursement structures, and national decision-making frameworks. These factors represent inherent limitations of international comparisons. The analysis is therefore intended as a comparative and contextual assessment rather than a formal cost-effectiveness evaluation within a single national reimbursement framework, particularly as no officially established uniform willingness-to-pay threshold per QALY exists in Germany.<h4>Clinical trial registration</h4>Not applicable. This study does not involve interventional clinical research. The protocol was registered on the Open Science Framework ( https://osf.io/24ky5 ).