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Does closed-loop automated oxygen control reduce the duration of mechanical ventilation? A randomised controlled
Ourania Kaltsogianni1, Theodore Dassios2,3, Anne Greenough4,5,6
1Neonatal Intensive Care Centre, King's College Hospital NHS Foundation Trust, 4th Floor Golden Jubilee Wing, Denmark Hill, London, SE5 9RS, UK.
Insights
Closed-loop automated oxygen control (CLAC) systems may reduce mechanical ventilation duration in preterm infants. This study compares CLAC to manual control, assessing its impact on ventilation time and infant outcomes.
Area of Science:
- Neonatal Medicine
- Respiratory Care
- Medical Technology
Background:
- Preterm infants often experience fluctuating oxygen saturation levels, increasing complication risks.
- Manual oxygen control requires frequent adjustments, impacting clinical workload.
- Closed-loop automated oxygen control (CLAC) systems show promise in stabilizing oxygen saturation and reducing manual interventions.
Purpose of the Study:
- To investigate if CLAC reduces the duration of mechanical ventilation in preterm infants (<31 weeks gestation) compared to manual oxygen control.
- To evaluate the impact of CLAC on key secondary outcomes including oxygen saturation variability and incidence of bronchopulmonary dysplasia.
Main Methods:
- Randomized controlled trial involving 70 preterm infants (<31 weeks gestation) requiring mechanical ventilation.
- Infants randomized to either CLAC or manual oxygen control until extubation.
- Primary outcome: duration of mechanical ventilation; Secondary outcomes: time in target saturation, hypoxia/hyperoxia exposure, manual adjustments, days on oxygen, bronchopulmonary dysplasia, length and cost of stay.
Main Results:
- This section is to be filled once the study is completed and results are available.
Conclusions:
- This trial will determine the efficacy of CLAC in reducing mechanical ventilation duration, a critical factor linked to adverse outcomes like bronchopulmonary dysplasia in preterm infants.
Background:
Many preterm infants require supplemental oxygen in the newborn period but experience frequent fluctuations of their oxygen saturation levels. Intermittent episodes of hypoxia or hyperoxia increase the risk of complications. Compliance with achievement of oxygen saturation targets is variable, and the need for frequent adjustments of the inspired oxygen concentration increases workload. Closed-loop automated oxygen control systems (CLAC) improve achievement of oxygen saturation targets and reduce both episodes of hypoxia and hyperoxia and the number of manual adjustments. This study investigates whether CLAC compared with manual oxygen control reduces the duration of mechanical ventilation in preterm infants born at less than 31 weeks of gestation.
Methods:
This randomised controlled trial performed at a single tertiary neonatal unit is recruiting 70 infants born at less than 31 weeks of gestational age and within 48 h of initiation of mechanical ventilation. Infants are randomised to CLAC or manual oxygen control from recruitment until successful extubation. The primary outcome is the duration of mechanical ventilation, and secondary outcomes are the percentage of time spent within target oxygen saturation ranges, the time spent in hypoxia or hyperoxia, the number of manual adjustments required, the number of days on oxygen, the incidence of bronchopulmonary dysplasia and the length and cost of neonatal unit stay. The study is performed following informed parental consent and was approved by the Yorkshire and the Humber-Sheffield Research Ethics Committee (protocol version 1.1, 13 July 2021).
Discussion:
This trial will investigate the effect of CLAC on the duration of mechanical ventilation, which is an important clinical outcome as prolonged mechanical ventilation is associated with important adverse outcomes, such as bronchopulmonary dysplasia.
Trial Registration:
ClinicalTrials.Gov NCT05030337 . Registered on 17 August 2021.
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