Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)

Vyaire Medical

Status: Completed

Conditions: Respiratory Insufficiency in Children

Treatments: Device: Volume Targeted Ventilation

Study type: Observational

Funder types: Industry

Identifiers

NCT05229172

CS-21-003-PaVoG

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 76 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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