RecruitingNot ApplicableNCT05030337

Optimising Ventilation in Preterms With Closed-loop Oxygen Control

Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants


Sponsor

King's College Hospital NHS Trust

Enrollment

70 participants

Start Date

Sep 5, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored. Oxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). 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 but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner. With this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.


Eligibility

Inclusion Criteria1

  • Preterm infants less than 31 weeks completed gestation at birth requiring mechanical ventilation and admitted to King's NICU in the first 48 hours after birth

Exclusion Criteria2

  • Preterm infants above 31 weeks completed gestation or term born infants
  • Infants with major congenital abnormalities

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Interventions

DEVICEClosed-loop automated oxygen control (Oxygenie, SLE 6000)

The OxyGenie closed-loop oxygen saturation monitoring software (SLE) uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.


Locations(1)

King's College Hospital NHS Foundation Trust

London, United Kingdom

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NCT05030337


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