This prospective observational study will evaluate the safety and performance of the Novalung ultimate kit in combination with the Xenios 2.0 and the MultiSupport Ground during stationary use in hospital and ground-based transport of patients treated on extracorporeal membrane oxygenation (ECMO). The primary objective is to assess whether the use of the medical devices improves and maintains the gas exchange (blood oxygenation) in these patients. Medical Devices will be used according to their intended purpose and local standards/ requirements.
Adult patients receiving an ECMO treatment with the Novalung ultimate kit in combination with the Xenios 2.0 (and the MultiSupport Ground during inter- and intra-hospital transport, if applicable) according to the intended use
Informed consent signed and dated by the attending physician; and
If patient is able to give consent: by the study patient
If patient is unable to give consent: by the legal representative or
Participation in any interventional clinical study that could impact the results of this prospective, observational PMCF study
Previous participation in the same study
ECMO cannulation outside the referring or trial site hospital
Xenios AG
Lead sponsor
Alcedis GmbH
Collaborator