Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2's Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cerebral oxygenation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 10 Minutes (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Term infants
- •Elective caesarean section
Exclusion Criteria
- •Thick hair that makes good measurements difficult/impossible
- •obvious malformations or syndromes
- •Complications in relation to caesarean section
- •Depression after birth (APGAR < 8 after 1 minute)
Outcomes
Primary Outcomes
Cerebral oxygenation
Time Frame: 10 minutes
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.
Secondary Outcomes
- Reproducibility(10 minutes)
Investigators
Gorm Greisen
professor
Rigshospitalet, Denmark