Klinik für Kinder- und Jugendmedizin Klinikum Traunstein
Traunstein, 83278, Germany
NCT Number: NCT04873999
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).
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Notify MeUp to 11 year
All sexes
Observational
Traunstein, 83278, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Drägerwerk AG & Co. KGaA
Industry
Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500) to Monitor Changes in Lung Ventilation Over Time in Mechanically Ventilated Children.
Acronym: PV500ped
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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.