NCT Number: NCT07156669
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
University Hospital Aachen, Aachen, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Anja Derlet-Savoia, Dr.
CONTACT
Fiona Bellando
CONTACT
Xenios AG
Industry
Acronym: Transport+
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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