Agreement in oxygen saturations study
Research type
Research Study
Full title
A study of agreement between oxygen saturation measured by different probes in infants on the neonatal unit
IRAS ID
297715
Contact name
Shalini Ojha
Contact email
Sponsor organisation
University of Nottingham
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Infants on the neonatal unit often require continuous monitoring of blood oxygen levels. This is a key component of neonatal care and NICE recommends that all preterm babies and those with suspected breathing or heart problems must have oxygen levels measured.\n\nBlood oxygen level is measured by passing a light through the foot or hand and measuring the absorbed light to calculate the level of oxygen in the blood. The light is attached to the infants hand/foot by a tie or a sticker called the probe. Several different types of probes are available for use in infants. \n\nIn the neonatal unit in Derby, two kinds of probes are used - Mindray 520 N and Mindray 521 N. Both probes are CE marked and used within their licensed indications. They are safe to use and painless to apply. \n\nStaff and parents noticed that the two probes, sometimes, give different readings. If true, this can cause problems in infants’ medical care. We therefore, want to check the agreement between the two probes. In this study, with written informed consent from parents, we will recruit 20 infants who are having their oxygen levels monitored. We will check their oxygen levels with both probes, simultaneously and measure the agreement between the two recordings.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0067
Date of REC Opinion
31 May 2021
REC opinion
Favourable Opinion