Transport+Novalung Ultimate Kit and Xenios 2.0 for ECMO Patients
The study observes the use of Novalung Ultimate Kit and Xenios 2.0 in patients undergoing extracorporeal membrane oxygenation to gather insights on their performance and potential benefits.
Data Collection
Collected from today forward - ProspectiveLung Diseases+1
+ Respiratory Tract Diseases
+ Lung Injury
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: October 1, 2025
Actual date on which the first participant was enrolled.This study focuses on examining the safety and performance of a specific medical device setup, which includes the Novalung ultimate kit and Xenios 2.0, used for patients on extracorporeal membrane oxygenation (ECMO). ECMO is a treatment that supports the heart and lungs when they are unable to function properly. The study is important because it looks at whether this setup can improve and maintain blood oxygen levels in patients, which is crucial for their recovery. It targets patients who are receiving ECMO treatment in hospitals and during transportation on the ground. In this observational study, participants are those who are already receiving ECMO support. The medical devices will be used as they are supposed to be according to existing standards and practices. The study will observe their use both when patients are stationary in a hospital and during their transportation. The main aim is to see if the devices effectively support and maintain the patient's blood oxygenation throughout the treatment and transport. There are no specific interventions or risks mentioned, as the study observes the natural use of these devices in real-world settings.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives