fabian Prospective Assessment of Volume Guarantee (fabian PaVoG)

• Research type

  Research Study

• Full title

  Prospective multicenter observational study of the safety and performance of fabian ventilator system Volume Guarantee mode in routine use

• IRAS ID

  307427

• Contact name

  Gusztav Belteki

• Contact email

  gusztav.belteki@addenbrookes.nhs.uk

• Sponsor organisation

  Vyair Medical

• Clinicaltrials.gov Identifier

  NCT05229172

• Duration of Study in the UK

  1 years, 5 months, 30 days

• Research summary

  A prospective, multicentre, single-cohort post market observational study, which will analyse data from neonatal and paediatric patients, who are ventilated with the fabian ventilator when the Volume Guarantee feature is in use.
  The objective of the study is to evaluate the volume guarantee function on the fabian ventilator in routine clinical use. The primary goal is to confirm that the system delivers the tidal volumes selected by the clinician during of the Volume Guarantee function in the neonatal intensive care unit.
  

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  22/SC/0066

• Date of REC Opinion

  6 May 2022

• REC opinion

  Further Information Favourable Opinion