Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility..
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Cerebral oxygenation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 2 Minutes (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Term infants (age more than 37 weeks of gestation)
- •Elective cesarean section after an uncomplicated pregnancy
- •Exclusion criteria:
- •Thick hair that makes good measurements difficult/impossible
- •Obvious malformations or syndrome
- •Complications in relation to the cesarean section
- •Depression after birth (APGAR < 8 after 1 minute)
Exclusion Criteria
- Not provided
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 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.
Secondary Outcomes
- Reproducibility(10 minutes)
Investigators
Gorm Greisen
Professor, MD
Rigshospitalet, Denmark