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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Xenios AG
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Arterial oxygen saturation (SaO2) [%]
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Extracorporeal Life Support (ECLS)
Patients who receive ECLS treatment and require a ground-based inter- hospital patient transport and/ or stationary treatment on ECMO
干预措施: Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG) (Device)
结局指标
主要结局
Arterial oxygen saturation (SaO2) [%]
时间窗: 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.
Arterial oxygen saturation (SaO2) [%]
时间窗: 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.
次要结局
- Performance objective Cardiacirculation(Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days)
- Performance objective Pump speed(Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days)
- Safety objectives(Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days)
- Performance objective Cardiacirculation(Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days)
- Performance objective Maintenance of blood flow(Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days)
- Performance objective Pump speed(Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days)
- Performance objective Circuit pressures(Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days)
- Safety objectives(Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days)