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Clinical Trials/NCT01693016
NCT01693016
Completed
N/A

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

Johannes Gutenberg University Mainz1 site in 1 country81 target enrollmentSeptember 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Non-invasive Hb Measurement in Children
Sponsor
Johannes Gutenberg University Mainz
Enrollment
81
Locations
1
Primary Endpoint
correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
January 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Johannes Gutenberg University Mainz
Responsible Party
Principal Investigator
Principal Investigator

Dr. Eva Wittenmeier

Dr. Eva Wittenmeier

Johannes Gutenberg University Mainz

Eligibility Criteria

Inclusion Criteria

  • children (\>= 3 kg until 8 years)
  • ASA I-III
  • written informed consent of legal representative

Exclusion Criteria

  • children \<= 3kg or \> 8 years
  • emergency surgery
  • allergy against sensor of SpHb(®)
  • artery occlusive disease
  • haemoglobinopathy
  • specific medical or psychological circumstances which do not allow the consent of the legal representative or the performance of the study

Outcomes

Primary Outcomes

correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia

Time Frame: one day

Secondary Outcomes

  • influence of inhalation anesthetics(one day)

Study Sites (1)

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