Optimising Ventilation in Preterms With Closed-loop Oxygen Control

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorKing's College Hospital NHS Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Preterm infants above 31 weeks completed gestation or term born infants

Infants with major congenital abnormalities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Closed-loop automated oxygen control (Oxygenie, SLE 6000)

    Device

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Manual oxygen controlNo intervention 0 interventions
Group B: Closed-loop automated oxygen controlOther 1 intervention

Trial outcomes

Primary outcomes

1

The duration of mechanical ventilation

The duration of mechanical ventilation will be measured in median (interquartile range) number of days of ventilation for participants in each group.

Time frame
Through study completion, an average of 2 years

Secondary outcomes

1

The percentage of time spent within target oxygen saturation range.

Target oxygen saturation range for our preterm population is 90-95% as per local guideline. The time spent in target range will be calculated as a percentage of the total time of monitoring.

Time frame
Through study completion, an average of 2 years
2

Number of manual adjustments to the inspired oxygen concentration required by clinical staff.

The number of manual adjustment will be calculated by reviewing the infant's medical records.

Time frame
Through study completion, an average of 2 years
3

Number of days on oxygen.

The number of days each participant will require supplementary oxygen to maintain oxygen saturation levels within target range.

Time frame
Through study completion, an average of 2 years
4

Length of Intensive Care stay

The days each participant is admitted at the Neonatal Intensive Care

Time frame
Through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College Hospital NHS Trust

Lead sponsor

King's College London

Collaborator