Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2
Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs. 1.2 (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective caesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. The Adult Somasensor (INVOS) will be used together with the OxyPrem sensor.
Near-infrared Spectroscopy, Transition, Caesarean Section
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2's Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility|
- Cerebral oxygenation [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]The sensors of both instruments will be placed on each side of the head. They will be held by hand by self-adhesive tape as appropriate.
- Reproducibility [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]The sensor will be placed 6 times alternating on each frontoparietal region and held by hand, obtaining 30 seconds of signal for each placement. The placements will be in the same region but not in exactly the same spot. This will be done for both devices.
|Study Start Date:||January 2013|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Near-infrared spectroscopy sensors
Term infants born by elective Caesarean section
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771601
|Copenhagen, Denmark, 2100|