In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.
Recorded data on brain tissue oxygenation will be compared with reference data obtained from other studies. Data from experimental mode (automated FiO2 control will be compared with manual FiO2 control).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Infants will be ventilated with or without automated FiO2-Control in a randomized sequence.
Children's Hospital University of Ulm
Ulm, Germany
Cerebral tissue oxygen saturation
mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed
Time frame: 48 hours
number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)
The number and mean duration of expisodes of desaturation and with hyperoxemia will be assessed
Time frame: 48 hours
time within a defined target range of cerebral oxygen saturation (59% - 81%)
time (as measured as the percentage of the total recording time) within a defined target range of cerebral oxygen saturation (59% - 81%) which corresponds to the 10th and 90th percentile obtained from a pilot study in 16 preterm infants with desaturations during the time when their SpO2 was aimed within the target range of a SpO2 of (88-96%).
Time frame: 48 hours
workload for the medical staff related to number of adjustments of FiO2
Time frame: 48 hours
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