Clinical Trials Directory

Trials / Completed

CompletedNCT01693016

Validation of Non-invasive Hemoglobin (SpHb) Measurement in Children

Validation of Non-invasive Hb-measurement (SpHb) in Children With the Masimo@ Radical 7

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
81 (actual)
Sponsor
Johannes Gutenberg University Mainz · Academic / Other
Sex
All
Age
8 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the value of the new technique of non-invasive measurement of Hb in children undergoing a surgical procedure.

Detailed description

Several surgical procedures require haemoglobin monitoring due to possible blood loss and the need of blood transfusion. The standard for monitoring hemoglobin (Hb) is the measurement of blood samples. The novel technique of non-invasive continuous measurement of Hb using Pulse CO-Oximetry may allow measuring Hb without obtaining blood samples. This new technique has not been tested yet in children undergoing anesthesia for elective surgical procedures. In this study the investigators compare the non-invasive Hb measurement with Masimo® technology (SpHb) with the standard Hb measurement using ABL-800 Flex (BGA) and Siemens Advia (labHb, reference method) before the children undergo the surgical procedure.

Conditions

Interventions

TypeNameDescription
DEVICEnon-invasive measurement of Hb
PROCEDUREtaking blood samples

Timeline

Start date
2012-09-01
Primary completion
2013-01-01
Completion
2013-01-01
First posted
2012-09-26
Last updated
2014-03-26

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01693016. Inclusion in this directory is not an endorsement.