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
Patients with severe acute respiratory and/or cardiopulmonary failure treated on ECMO.
Other
Prospective
Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)
DevicePatients will receive ECLS treatment using the Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG) during ground-based inter-hospital patient transport and/ or stationary treatment according to their intended use and local standards/ requirements.
Arterial oxygen saturation (SaO2) [%]
Longitudinal assessments of continuous outcomes will be analyzed by treatment day using mixed models for repeated measures (MMRM), with ECMO mode as a fixed factor (except for analyses performed within the subsets defined by ECMO mode) and the baseline value of the primary endpoint as a covariate. Within-subject differences between baseline and subsequent visits will be tested using contrasts. The comparison between baseline and the first day on ECMO (initial effect) is considered as the primary outcome.
Performance objective Cardiacirculation
Improvement and maintenance of patients' cardiocirculation in patients transported and treated stationary on ECMO
Performance objective Maintenance of blood flow
Evaluation of Xenios 2.0 performance during transport and stationary use: Maintenance of blood flow (L/min)
Performance objective Pump speed
Evaluation of Xenios 2.0 performance during transport and stationary use: Pump speed (rpm)
Performance objective Circuit pressures
Evaluation of Xenios 2.0 performance during transport and stationary use: Circuit pressures (mmHg)
Click on the lead sponsor to view all of their trials.
Xenios AG
Lead sponsor
Alcedis GmbH
Collaborator
