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Servo-n HFOV Study: Safety and Performance in Neonates and Infants
Sponsor: Maquet Critical Care AB
Summary
The purpose of this study is to evaluate the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes of the Servo-n ventilator in neonates and infants, by using a prospective, observational, single-arm (i.e., non-controlled) and multi-center Post-Market Follow-up (PMCF) study design. HFOV treatment will be evaluated by assessing ventilation and oxygenation variables, and safety will be evaluated by documentation of device related adverse events.
Official title: Servo-n High-Frequency Oscillatory Ventilation in Clinical Practice: A Prospective, Observational, Single-arm and Multi-center Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
75
Start Date
2024-07-15
Completion Date
2026-12-31
Last Updated
2025-04-03
Healthy Volunteers
No
Conditions
Interventions
Servo-n HFOV modes
Treatment with high frequency oscillatory ventilation with Servo-n device in accordance to Standard of Care
Locations (4)
CHU Montpellier-Arnaud de Villeneuve
Montpellier, France
Antoine-Béclère Hospital
Paris, France
Poznan University of Medical Sciences
Poznan, Poland
University Hospital of Geneva (HUG),
Geneva, Switzerland