SCO2T study (SpO2: Masimo vs. Nellcor)
Research type
Research Study
Full title
SCO2T Study (Servo Controlled Oxygen Targeting) A randomised crossover study comparing pulse oximeter technology using automatic oxygen control for preterm infants
IRAS ID
288019
Contact name
Ben Stenson
Contact email
Sponsor organisation
ACCORD, University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better. \n\nKeeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best. \n\nOur research suggests that different automated devices control oxygen effectively as measured by the readings from their internal oxygen saturation monitoring systems. When compared to free-standing saturation monitors there appears to be variations in measured oxygen levels between devices. This could have important clinical implications. \n\nThis study aims to show the different achieved oxygen levels when babies are targeted to a set target range. Babies in the study will have both a saturation monitor and a transcutaneous oxygen monitor at the same time. Both types of monitor have been in long term use in neonatal units. \n\nFor a period of 12 hours, each baby will have their oxygen adjusted automatically using two different internal oxygen monitoring technologies (6 hours respectively). We will compare the range of oxygen levels that are seen between the two oxygen saturation monitoring technologies. \n\nWe will study babies born at less than 30 weeks gestation, who are at least 2 days old, on nasal high flow and still require added oxygen.
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0109
Date of REC Opinion
30 Sep 2020
REC opinion
Favourable Opinion