Paediatric Oximetry Algorithms
Research type
Research Study
Full title
PAEDIATRIC OXIMETRY ALGORITHMS – NORMATIVE DATA COLLECTION
IRAS ID
222270
Contact name
Heather Elphick
Contact email
Sponsor organisation
Sheffield Children's Hospital NHS Trust
Duration of Study in the UK
0 years, 3 months, 4 days
Research summary
Children with long-term respiratory conditions such as chronic lung disease of prematurity and muscular dystrophy need frequent monitoring of their blood oxygen concentrations to assess levels of treatment required (e.g. oxygen therapy, ventilation). Such conditions can lead to severe illness or death if oxygen levels are not monitored and appropriate action taken. Currently, blood oxygen levels are monitored at home using pulse oximetry with monitors that are cumbersome and not optimised for movement and paediatric reference values. This leads to inaccurate readings, especially at times when oxygen may be needed most, for example, during feeding and activity. Accurate monitoring will allow targeted treatment when children most need it.
There is no pulse oximeter currently available which can accurately monitor patients able to ambulate and which uses bespoke paediatric algorithms to obtain accurate results from children of different sizes.
At a recent Technology Innovation Transforming Child Health (TITCH) Network meeting the above problems were identified and a collaborative team was set up. This working group consists of Viamed; a medical device company who have worked in the field of pulse oximetry for 40 years, Medilink Yorkshire and Humber; who will provide the project management along with innovation and commercialisation expertise; and the Respiratory and Sleep team at Sheffield Children’s Hospital (SCH) who will provide the clinical and research expertise. The team have recently been successful in being awarded £93,318 for 6 month phase 1 funding from the Small Business Research Initiative Scheme (SBRI). The key end point and key output of phase 1 is to design a wearable paediatric oximetry probe.
The first stage of this project is to collect clinical data from children undergoing oximetry monitoring to be able to create bespoke paediatric algorithms. This protocol outlines the normative data collection process of existing clinical algorithms using existing oximetry technology.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0483
Date of REC Opinion
16 Mar 2017
REC opinion
Favourable Opinion