Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters
This study has been completed.
Information provided by (Responsible Party):
Tomasz Szczapa, Poznan University of Medical Sciences
First received: December 10, 2011
Last updated: September 9, 2013
Last verified: September 2013
The aim of the study is to compare the values of cerebral tissue oxygenation measured simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.
||Observational Model: Case-Only
Time Perspective: Prospective
||A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters
Primary Outcome Measures:
- Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
There are two FDA-approved near infrared cerebral oximeters:
- FORE-SIGHT- which uses laser light
- INVOS 5100- which uses light emmiting diode.
Measurements in adult patients have showed that FORE-SIGHT provides more stable signal. Purpose of our study is to compare these two devices in newborn patients.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Preterm Newborns (32-37 GA)
|Ages Eligible for Study:
||up to 1 Day
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Clinically stable, spontaneously breathing newborns will be included in the study. Enrolled patients will be divided into two groups: 15 term (≥37 weeks GA) and 15 preterm (32-37 weeks GA) newborns. NIRS measurements will be performed on the 1st and 3rd day of life.
- Clinically stable
- Spontaneously breathing newborns
- Congenital heart defects or anomalies of central nervous system
- Prematurity below 32 GA
- Respiratory distress
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496027
|Poznań, Wielkopolskie, Poland, 60-535 |
Poznan University of Medical Sciences
MacLeod D; Ikeda K; Vacchiano C Simultaneous Comparison of FORE-SIGHT and INVOS Cerebral Oximeters to Jugular Bulb and Arterial Co-Oximetry Measurements in Healthy Volunteers ANESTH ANALG 2009; 108(SCA Suppl);1-104
||Tomasz Szczapa, M.D., Poznan University of Medical Sciences
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 10, 2011
||September 9, 2013
||Poland: Ethics Committee
Keywords provided by Poznan University of Medical Sciences:
ClinicalTrials.gov processed this record on July 27, 2015
near infrared spectroscopy