Closed-loop oxygen control in ventilated infants born at or near term
Research type
Research Study
Full title
Does closed-loop automated oxygen control during mechanical ventilation reduce hypoxic events? A randomised controlled crossover study in ventilated infants
IRAS ID
298164
Contact name
Anne Greenough
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
Ventilated neonates frequently require supplementary oxygen to allow for adequate oxygen delivery to the tissues and normal cell metabolism. Oxygen treatment should be monitored carefully as both excessive and inadequate dosing can have detrimental effects for the infants. Hypoxia (giving too little oxygen) increases mortality and later disability whereas hyperoxia (giving too much oxygen) increases the risk of complications such as retinopathy of prematurity and lung disease. Although very preterm and low birth weight infants represent the majority of ventilated neonates, more mature infants may also require mechanical ventilation at birth and provision of supplementary oxygen. Therefore, they may suffer from complications related to hypoxia or hyperoxia. Hence, their oxygen saturation levels and the amount of the inspired oxygen concentration provided should be continuously monitored.
Oxygen 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. The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range, decreases the duration of hypoxia and hyperoxia and reduces the number of manual adjustments required by clinical staff. However previous studies have been limited to very small infants. With this study we want to evaluate the effectiveness of CLAC in ventilated infants born at 34 weeks gestation and beyond. We will compare achievement of oxygen saturation targets between CLAC and manual control and the number of manual adjustments required in a cohort of patients that has not been included in previous studies and could also benefit from the intervention. We will also evaluate if CLAC reduces investigations performed to ventilated babies(blood gases, X-rays).Summary of Results
Thirty-one infants with a median gestational age of 37.9 weeks (range: 37.1-38.9 weeks) were studied at a median postmenstrual age of 38.9 weeks (range: 37.4-39.8) weeks. In infants with more severe lung disease, defined as an oxygen requirement at or above 30%, closed-loop automated oxygen control (CLAC) increased the percentage of time spent in the target oxygen range (92-96%) by 61.6% (p=0.018), whereas in infants with a less severe lung disease and a lower oxygen requirement (<30%), the time in target was increased by 3.8% (p=0.019). During CLAC, only infants with more severe lung disease spent less time in hyperoxemia (SpO2>96%) and hyperoxemic episodes were shorter. In both groups, CLAC reduced the duration of desaturations (SpO2<92%). In infants with congenital diaphragmatic hernia, CLAC increased the time spent in target oxygen range by 34% and the median duration of desaturations was reduced.
Therefore, we concluded that CLAC may be more useful in infants with more severe respiratory distress.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0140
Date of REC Opinion
16 Jul 2021
REC opinion
Further Information Favourable Opinion