CLIO-VG Study version 1.0
Research type
Research Study
Full title
Comparison of automated oxygen control (closed loop inspired oxygen: CLIO) with and without automated pressure control (Volume Guarantee®) in preterm ventilated infants: A crossover study (CLIO-VG Study)
IRAS ID
249139
Contact name
VRINDA NAIR
Contact email
Sponsor organisation
South Tees NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Oxygen treatment is common in babies born early (preterm) and requiring intensive care. Having too much or too little oxygen can increase the risk of damage to the eyes and lungs, and contribute to death or disability. It is therefore important to keep oxygen levels in the blood (‘oxygen saturation’) within a safe, targeted range. Traditionally, health carers manually adjust the amount of oxygen given on the breathing machine (ventilator). It is now possible to adjust the amount of oxygen given automatically, and we have shown in previous research that the use of automatic adjustment is better at keeping oxygen levels in the target range. We now wish to study whether further improvements can be made, in keeping oxygen saturation levels in target range by adding a specific type of breathing support called Volume Guarantee®. This type of breathing support ensures that the amount of gas given into the baby’s lungs in each breath is consistent, through breath-to-breath adjustment of the pressure in the ventilator. This type of ventilation is used commonly, but has not been studied together with the automatic oxygen control. The study will be conducted in a tertiary neonatal intensive care unit at the James Cook University Hospital, Middlesbrough, UK. Eligible infants will be preterm infants born at less than 32 weeks gestation who are receiving breathing support (ventilation) through a breathing tube and who require oxygen at the time of enrolment. Babies will participate in the study for a 24-hour period; 12 hours with automatic adjustment of oxygen and Volume Guarantee®; and 12 hours with automatic adjustment of oxygen without Volume Guarantee®. The amount of time that the oxygen saturation remains within target range will be compared between the 2 periods. All other treatment and care of the baby will remain exactly the same as our standard.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0094
Date of REC Opinion
23 May 2019
REC opinion
Further Information Favourable Opinion