IntellO2 vs Manual Control for Optimizing Oxygenation in Infants
Research type
Research Study
Full title
Comparison of the IntellO2 - Precision Flow automatic FiO2 controller to Manual Control for optimizing oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy
IRAS ID
150869
Contact name
Peter Reynolds
Contact email
Sponsor organisation
Vapotherm, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 31 days
Research summary
Infants in the Neonatal ICU environment often require frequent changes in the percent of oxygen they receive (FiO2) to maintain their arterial blood oxygen saturation in the proper range. Stability of blood oxygen saturation and the time spend in the ideal range is an important health issue for these infants. Conventional practice is for the caregivers to manually adjust FiO2 as needed based on the pulse oximetry reading for blood oxygen saturation (SpO2), but the infants can spend significant time outside of the intended range. This study evaluates a device, IntellO2, for automated FiO2 adjustment based on real-time measure of SpO2. The hypothesis is that IntellO2 will allow for infants to spend more time in the target SpO2 range over a 24 hr period, with potentially less overall exposure to oxygen.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/1272
Date of REC Opinion
25 Jul 2016
REC opinion
Favourable Opinion