Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alcedis GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal Life Support (ECLS) | Patients who receive ECLS treatment and require a ground-based inter- hospital patient transport and/ or stationary treatment on ECMO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Performance objective Cardiacirculation | Improvement and maintenance of patients' cardiocirculation in patients transported and treated stationary on ECMO | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days |
| Performance objective Maintenance of blood flow |
Not provided
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with severe acute respiratory and/or cardiopulmonary failure treated on ECMO.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anja Derlet-Savoia, Dr. | Contact | +49 6172 268 6648 | Anja.Derlet@freseniusmedicalcare.com | |
| Fiona Bellando | Contact | fiona.bellando@freseniusmedicalcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Heinrich Groesdonk, Prof. Dr. med. | HELIOS Hospital, Erfurt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Aachen | Aachen | 52074 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Evaluation of Xenios 2.0 performance during transport and stationary use: Maintenance of blood flow (L/min) |
| Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days |
| Performance objective Pump speed | Evaluation of Xenios 2.0 performance during transport and stationary use: Pump speed (rpm) | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days |
| Performance objective Circuit pressures | Evaluation of Xenios 2.0 performance during transport and stationary use: Circuit pressures (mmHg) | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days |
| Safety objectives | 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. | Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days |
| Krankenhaus Bethanien gGmbH | Solingen | 42699 | Germany |
|
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided