NCT04873999

Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500)

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Drägerwerk AG & Co. KGaA · Industry
• Sex: All
• Age: 11 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Monitoring of Regional Distribution of Ventilation
• Monitoring of Lung Volume

Timeline

• Start date: 2021-05-03
• Primary completion: 2021-07-28
• Completion: 2021-07-28
• First posted: 2021-05-05
• Last updated: 2022-03-29

Locations

1 site across 1 country: Germany