Transport+Kit Ultimate de Novalung y Xenios 2.0 para pacientes con ECMO
El estudio observa el uso del Novalung Ultimate Kit y Xenios 2.0 en pacientes sometidos a oxigenación por membrana extracorpórea para recopilar información sobre su rendimiento y posibles beneficios.
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades del pulmón
+ Enfermedades del Tracto Respiratorio
Otro
Uso de métodos específicos que no están cubiertos por los modelos estándar para abordar preguntas de investigación únicas.Resumen
Fecha de inicio: 1 de octubre de 2025
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios