This observational PMCF study will be conducted to generate and gather clinical data from the intended target population of pediatric patients. The intention for Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of a device throughout the device's lifecycle. PulmoVista 500 is a lung function monitor for clinical use which continuously generates cross-sectional images of the lung function by applying the technique of electrical impedance tomography (EIT).
Study Type
OBSERVATIONAL
Enrollment
23
Klinik für Kinder- und Jugendmedizin Klinikum Traunstein
Traunstein, Germany
assess the capability of PulmoVista 500 for continuous monitoring of ventilation
To assess the capability of PulmoVista 500 for continuous monitoring of ventilation, the cross-correlation function (CCF) between the global impedance waveform of EIT and global tidal volume waveforms of a ventilator across multiple respiratory cycles in patients under controlled mechanical ventilation, will be evaluated.
Time frame: Duration per participant: 2 - 3 days (screening, procedure with PulmoVista 500, safety follow-up). Measurements with PulmoVista 500 per patient during mechanical ventilation is anticipated for a maximum of 10 minutes in total.
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