Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters
Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective cesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be used.
Near Infrared Spectroscopy
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters 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 or by self-adhesive tape as appropriate.
Curve fitting will be used to describe the rapid increase of oxygenation after birth. Estimated cerebral oxygenation at 3 min (hypoxia) and 10 min (normoxia) will be used to compare the two instruments.
- 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:||August 2012|
|Study Completion Date:||November 2012|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665287
|Department of Neonatology, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Gorm Greisen, Professor||Not relevant|