Respiratory Insufficiency in Children Clinical Trial
Official title:
Prospective Multicenter Observational Study of the Safety and Performance of Fabian Ventilator System Volume Guarantee Mode in Routine Use
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product and will provide performance data on the Volume Guarantee function of the fabian ventilator in daily clinical routine.
PaVoG study is a prospective, multicenter, single-cohort post market observational study. The study procedures will be conducted according to standard of care of each participating hospital and the instructions for use of the study device. To allow data collection, an Informed Consent Form will be obtained from each study participant/ legally authorized representative, if required by the local Ethical Committee. Ventilator data will be recorded in the hospital's data capture system or on a study laptop provided by the Sponsor. Each patient will be clinically evaluated according to hospital standard of care. If inclusion and exclusion criteria are met, and the investigative team is available the patient will be enrolled. Study duration for an individual patient will differ, depending on the time spent on fabian ventilator with Volume Guarantee mode on. It is anticipated that for most will be between 2-4 days. ;
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