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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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients that visit the hospital for any kind of surgery, therefore requireing mechanical ventilation. Monitoring of Regional Distribution of Ventilation and Lung Volume are of clinical interest in these patients.
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Wolf, PD Dr. | Children's hospital Traunstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Kinder- und Jugendmedizin Klinikum Traunstein | Traunstein | 83278 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37046213 | Derived | Clasen D, Winter I, Rietzler S, Wolf GK. Changes in ventilation distribution during general anesthesia measured with EIT in mechanically ventilated small children. BMC Anesthesiol. 2023 Apr 12;23(1):118. doi: 10.1186/s12871-023-02079-z. |
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