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

Not Applicable

Completed

• Conditions: Non-invasive Hb Measurement in Children
• Interventions: Device: non-invasive measurement of Hb; Procedure: taking blood samples

• Registration Number: NCT01693016
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-26
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-23
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
inhalation group	non-invasive measurement of Hb	20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia
inhalation group	taking blood samples	20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia
non-inhalational	non-invasive measurement of Hb	40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children.
non-inhalational	taking blood samples	40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children.

Primary Outcome Measures

Name	Time	Method
correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia	one day

Secondary Outcome Measures

Name	Time	Method
influence of inhalation anesthetics	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.

Trial Locations

Locations (1)

Dr. Eva Wittenmeier; 🇩🇪 Mainz, Germany