SCO2T study (Servo vs. Servo)
Research type
Research Study
Full title
SCO2T study (Servo vs. Servo) Servo Controlled Oxygen Targeting
IRAS ID
280633
Contact name
Fraser G Christie
Contact email
Sponsor organisation
ACCORD, University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 00 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.
Keeping 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.
Studies of automated control have shown that infants spend more time within their intended target oxygen saturation range. These have not included measurements of transcutaneous oxygen. There are no previous studies directly comparing automated respiratory devices.
This study aims to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted using two automated (servo) control devices delivering nasal high flow
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.
For a period of 12 hours each baby will have their oxygen adjusted automatically using each devices for 6 hours respectively. We will compare the range of oxygen levels that are seen between the two respiratory devices.
We will study babies born at less than 30 weeks gestation, who are at least 2 days old, clinically stable on nasal high flow and still require added oxygen.
REC name
West of Scotland REC 1
REC reference
20/WS/0081
Date of REC Opinion
9 Jun 2020
REC opinion
Favourable Opinion