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RECRUITING
NCT06114992

Servo-n HFOV Study: Safety and Performance in Neonates and Infants

Sponsor: Maquet Critical Care AB

View on ClinicalTrials.gov

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

Interventions

DEVICE

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