Dual Loop alogorithm adjustment study in ventilated preterm infants
Research type
Research Study
Full title
Automated adjustment of inspired oxygen and tidal volume in ventilated preterm infants: crossover physiologic study
IRAS ID
210634
Contact name
Mithilesh Lal
Contact email
Sponsor organisation
South Tees NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Oxygen therapy is common in premature babies requiring intensive care. Whilst having too little oxygen can increase the risk of death/ disability, too much oxygen can cause injury to the eyes, lungs and brain. Hence it is important to maintain oxygen levels in blood (saturation, SpO2) within a 'target range'. Studies show that it is possible to maintain saturation levels within target range for about 50% of the time through manual adjustment of oxygen on the bedside. We and others have already shown that the use of automated adjustment of inspired oxygen allows for improved compliance with a presribed oxygen saturation target range and significant reduction in extremely high and low levels of oxygen in blood (hyperoxaemia and hypoxaemia).
Another mechanism of respiratory instability and hypoxaemia is wide fluctuation in tidal volume in ventilated preterm infants. Volume Guarantee (VG) is a mode of breathing support which allows a consistent tidal volume delivery through through breath-to-breath adjustment of pressure in the ventilator. There is no data available currently on whether automated adjustment of inspired oxygen and tidal volume leads to further improvements in maintaining SpO2 profile within prescribed target range and more importantly reduce episodes of prolonged hypoxaemia and hyperoxaemia.
The objective of this study was to evaluate the efficacy of the automatic FiO2 control function with or without volume guarantee in maintaining target range of SpO2 between 90 to 95%.
This will be conducted as a feasibility study as we can not be certain about the magnitude of effect due to VG. We aim to recruit 30 infants overall. This should still provide valuable information towards future studies and hypothesis generation.We will also conducted questionnaires at the end of the study to assess parents and staff opinion of the study.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
17/YH/0169
Date of REC Opinion
7 Jun 2017
REC opinion
Unfavourable Opinion