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

March 23, 2014 updated by: Dr. Eva Wittenmeier, Johannes Gutenberg University Mainz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • Dr. Eva Wittenmeier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • sepsis
  • haemoglobinopathy
  • specific medical or psychological circumstances which do not allow the consent of the legal representative or the performance of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: inhalation group
20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia
Device: non-invasive measurement of Hb
Other Names:
  • SpHb (®) by Masimo ® Radical 7
Procedure: taking blood samples
Other Names:
  • blood for BGA (ABL 800)
  • blood for laboratory Hb (Siemens Advia)
OTHER: non-inhalational
40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children.
Device: non-invasive measurement of Hb
Other Names:
  • SpHb (®) by Masimo ® Radical 7
Procedure: taking blood samples
Other Names:
  • blood for BGA (ABL 800)
  • blood for laboratory Hb (Siemens Advia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia
Time Frame: one day
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
influence of inhalation anesthetics
Time Frame: one day
The blood samples are taken from the needle infusion set the child gets for anesthesia. Some children will need an inhalational induction of anesthesia before they can get the needle and the sensor for the SpHb (®) monitoring. So an influence of the application of inhalation anesthetics on the accuracy of the SpHb (®) will be tested.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Eva Wittenmeier, Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

September 19, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (ESTIMATE)

September 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 23, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MASIMO 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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