Status:
COMPLETED
Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)
Lead Sponsor:
Vyaire Medical
Conditions:
Respiratory Insufficiency in Children
Eligibility:
All Genders
Brief Summary
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...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Patient ventilated with fabian ventilator (conventional or HFOV) with VG mode active.
- The anticipated use of VG mode is at least 12 hours
- Informed Consent given by parents or guardians according to the process approved by the local research ethical committee
Exclusion
- Patients with severe airflow obstruction and intracranial hypertension
- Decision documented to give palliative neonatal care.
- The clinical care team does not agree with inclusion of the infant to the study
Key Trial Info
Start Date :
February 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 27 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05229172
Start Date
February 24 2022
End Date
June 27 2023
Last Update
June 28 2023
Active Locations (5)
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1
University Medical Center Amsterdam, The Netherlands
Amsterdam, Netherlands
2
Szpital Położniczo - Ginekologiczny Ujastek
Krakow, Poland
3
Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, Poland, 60-535
4
Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego
Warsaw, Poland