Optimising neonatal ventilation with closed-loop oxygen control
Research type
Research Study
Full title
Does closed-loop automated oxygen control during mechanical ventilation reduce the duration of supplementary oxygen treatment and the amount of time spent in hyperoxia? A randomised controlled trial in ventilated infants born at or near term
IRAS ID
317426
Contact name
Theodore Dassios
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Ventilated neonates frequently require supplemental oxygen but its use should be monitored carefully as both excessive and inadequate dosing can have detrimental effects for the infants. Hypoxia (giving too little oxygen) increases morbidity and mortality whereas hyperoxia (giving too much oxygen) increases the risk of complications such as retinopathy of prematurity and lung disease. Although very preterm infants represent the majority of ventilated neonates, more mature infants may also require mechanical ventilation at birth and provision of supplemental oxygen. Therefore, they may suffer from complications related to hypoxia and hyperoxia. \nOxygen control is traditionally monitored and adjusted manually by the nurse looking after the infant. Closed-loop automated oxygen control (CLAC) is a more recent approach that involves the use of a computer software incorporated into the ventilator. CLAC systems automatically adjust the amount of oxygen provided to maintain oxygen saturation levels in a desired target range. Previous studies in preterm and very small infants demonstrated that CLAC improves compliance with target achievement, prevents hypoxia and hyperoxia and reduces the number of manual adjustments required by clinical staff. In an interim analysis of a study in ventilated neonates born at or above thirty-four weeks gestation, we demonstrated that CLAC is also effective on preventing hyperoxia and facilitated weaning of the oxygen provided to the patients. With this study we will compare the time spent in hyperoxia and the overall duration of supplementary oxygen treatment between infants receiving either CLAC or manual oxygen control for the whole duration of mechanical ventilation. These are important outcomes related to respiratory morbidity and the complications arising from oxygen treatment.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0225
Date of REC Opinion
9 Nov 2022
REC opinion
Further Information Favourable Opinion