Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters

Cerebral Oxygenation Clinical Trial

Official title:

A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496027
• Other study ID #: 04515
• Status: Completed
• Phase: N/A
• First received: December 10, 2011
• Last updated: September 9, 2013
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: September 2013
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

Inclusion Criteria:

• Clinically stable

• Spontaneously breathing newborns

Exclusion Criteria:

• Congenital heart defects or anomalies of central nervous system

• Prematurity below 32 GA

• Respiratory distress

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Oxygenation

Locations

Country	Name	City	State
Poland	Katedra Neonatologii	Poznan	Wielkopolskie

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns)	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.	6 hours	No