Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG).
- Who it may be relevant to
- Registry conditions: Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication, Acute Lung Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)
Patients 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.
Primary outcome measures
- Arterial oxygen saturation (SaO2) [%] [Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
Secondary outcome measures (5)
- Performance objective Cardiacirculation [Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
- Performance objective Maintenance of blood flow [Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
- Performance objective Pump speed [Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
- Performance objective Circuit pressures [Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
- Safety objectives [Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
Eligibility criteria
Inclusion criteria
- 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
- If an emergency situation is determined: by a consultant physician
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 2 centers
- University Hospital Aachen — Aachen
- Krankenhaus Bethanien gGmbH — Solingen
Identifiers
NCT: NCT07156669 · HL-ECMO-01-INT