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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
King's College Hospital NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Ourania Kaltsogianni, MSc
ourania.kaltsogianni@nhs.net
(+44)02032999000
Backup
Theodore Dassios, Consultant Neonatologist
theodore.dassios@nhs.net
Time Frame
Start Date: 2021-09-05
Estimated Completion Date: 2025-03
Participants
Target number of participants: 70
Treatments
No_intervention: Manual oxygen control
Standard ventilation with inspired oxygen concentration adjusted manually as per unit's protocol.
Other: Closed-loop automated oxygen control
Ventilation with Oxygenie software (closed-loop automated oxygen control system), adjusted by clinical staff as necessary
Sponsors
Leads: King's College Hospital NHS Trust
Collaborators: King's College London

This content was sourced from clinicaltrials.gov