Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters

Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility..

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01665287

Enrollment

Registered

2012-08-15

Start date

2012-08-31

Completion date

2012-11-30

Last updated

2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Near Infrared Spectroscopy

Keywords

Cerebral Oximetry, Near infrared spectroscopy, Fullterm, Infant

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Minutes

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)

Design outcomes

Primary

Measure	Time frame	Description
Cerebral oxygenation	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

Measure	Time frame	Description
Reproducibility	10 minutes	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.

Countries

Denmark

Outcome results