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Completed

NCT Number: NCT01693016

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

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.

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Key information

Conditions

Non-invasive Hb Measurement in Children

Age range

Up to 8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Eva Wittenmeier

Mainz, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-invasive measurement of Hb

Device

Other names: SpHb (®) by Masimo ® Radical 7

taking blood samples

Procedure

Other names: blood for BGA (ABL 800), blood for laboratory Hb (Siemens Advia)

Primary outcomes

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

    Time frame: one day

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2012
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.