To compare the effect of two automated oxygen controllers (Oxygenie and CLiO2) on time spent within oxygen target range in preterm infants.
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of time SpO2 spent within set target range (91-95%)
Secondary outcome
Time SpO2 spent above target range (SpO2 > 95%).
Time SpO2 spent below target range (SpO2 < 91%).
Coefficient of variation of SpO2.
Time in hypoxaemic SpO2 ranges (SpO2 85-90%, 80-84%, <80%).
Time in hyperoxaemic SpO2 ranges (SpO2 96-98% and >98%), when receiving
supplemental oxygen.
Frequency of episodes of hypoxaemia (SpO2 <85% and <80%) for >30 seconds and
>60 seconds.
Frequency of episodes of hyperoxaemia (SpO2 >=97% and >=99% when receiving
supplemental oxygen).
Frequency of episodes of bradycardia (HR <100 bpm more than 10 seconds).
Frequency of FiO2 adjustments during automated control, both made by the
controller, and by bedside staff as manual over-rides of the automated system.
Average oxygen exposure
Coefficient of variation of FiO2
Effects on nursing workload in relation to FiO2 adjustment (number of manual
FiO2 adjustments)
Confidence of the bedside staff in the automated control system
Background summary
Preterm infants often need respiratory support and supplemental oxygen for a
prolonged period of time during their admission in the NICU. While maintaining
the oxygen saturation within the narrow target range is important to prevent
morbidity, manual oxygen titration can be very challenging. Automatic
titration by an automated oxygen controller has been proven to be more
effective in this than manual control. However, to date the performance of
different oxygen controllers using different algorithms has not been compared.
Based on described differences in algorithm and reported effects of two
commercially-available oxygen controllers (CLiO2 and Oxygenie) we hypothesize
that the Oxygenie controller will lead to a more effective decrease in
occurrence of hypoxaemia without increasing the occurrence of hyperoxaemia when
compared to CLiO2.
Study objective
To compare the effect of two automated oxygen controllers (Oxygenie and CLiO2)
on time spent within oxygen target range in preterm infants.
Study design
Single blinded randomised cross-over study
Intervention
In both groups oxygen will be automatically titrated with the Oxygenie
controller and the CLiO2 controller for 25 hours in random sequence. Automated
oxygen control is standard care in our unit.
Study burden and risks
There is no additional burden for the patient as using an automated oxygen
controller is standard of care.
Considering the very short study period, there is no additional risk or benefit
when the previous automated oxygen controller (CLiO2) will be used to control
the fraction of inspired oxygen for 24 hours.
Preterm infants often need respiratory support and supplemental oxygen for a
prolonged period of time. Oxygen is often titrated in order to maintain the
SpO2 within the small therapeutic range. Both hypoxaemia and hyperoxaemia are
associated with morbidity and mortality in this group, and any intervention
aiming to reduce the risk therefore needs to be studied in this specific
population at risk.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Born between 24 weeks, 0 days and 29 weeks, 6 days of gestation. Receiving invasive mechanical ventilation or non-invasive respiratory support, receiving supplemental oxygen (at least 25%), with written informed parental consent.
Exclusion criteria
Major congenital anomalies, arterial hypotension, if attending physician considers the infant not stable enough for a switch between ventilators.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66058.000.18 |