Acute Lung Injury, Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication
Conditions
Keywords
Extracorporeal Life Support, Extracorporeal Membrane Oxygenation
Brief summary
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
DEVICENovalung 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.
Sponsors
Xenios AG
Alcedis GmbH
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 1. If patient is able to give consent: by the study patient 2. If patient is unable to give consent: by the legal representative or 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial oxygen saturation (SaO2) [%] | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance objective Cardiacirculation | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days | Improvement and maintenance of patients' cardiocirculation in patients transported and treated stationary on ECMO |
| Performance objective Maintenance of blood flow | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days | Evaluation of Xenios 2.0 performance during transport and stationary use: Maintenance of blood flow (L/min) |
| Performance objective Pump speed | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days | Evaluation of Xenios 2.0 performance during transport and stationary use: Pump speed (rpm) |
| Performance objective Circuit pressures | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days | Evaluation of Xenios 2.0 performance during transport and stationary use: Circuit pressures (mmHg) |
| Safety objectives | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days | Assessment of the safety of the use of the Xenios System for ground-based transport and stationary use of patients on ECMO. Complications will be grouped in device-, transport-, cannula-, and patient-related complications and presented as relative and absolute frequencies. |
Countries
Germany
Contacts
CONTACTAnja Derlet-Savoia, Dr.
CONTACTFiona Bellando
PRINCIPAL_INVESTIGATORMagdalena Römmer, Dr. med.
HELIOS Hospital, Erfurt, Germany
Outcome results
None listed