The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit. Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine. The infants will remain in the study as long as the Neosense measuring system is used.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
6
The Neosense umbilical catheter is used instead of the routinely used umbilical catheter
Karolinska University Hospital
Huddinge, Sweden
Uppsala University Children's Hospital
Uppsala, Sweden
Measurement performance of an intravascular oxygen sensor in the Neosense system.
The oxygen tension measured by the Neosense system, compared to the oxygen tension measured by a blood gas analyser.
Time frame: Average of measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)
Clinical complications with the Neosense catheter.
The number of occasions when the Neosense catheter had to be removed and the underlying reason. This includes all anticipated device effects as well as placing the catheter in the wrong vessel, impossible to measure blood pressure, collect blood samples and/or administer fluids.
Time frame: During study, up to 8 days
Any deviations from normal procedures when inserting an umbilical catheter.
Number of attempts to place the catheter for each patient. Any accessories needed to introduce or handle the Neosense catheter.
Time frame: During day 1
Number of monitor lockups or battery depletions
Timepoint for monitor lockup or battery depletion, in case of occurrence.
Time frame: During study, in average 4-5 days
Usability and functionality of the Neosense monitor.
Occurence of anticipated adverse device effects for the monitor.
Time frame: During study, in average 4-5 days
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