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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01693016
Enrollment
81
Registered
2012-09-26
Start date
2012-09-30
Completion date
2013-01-31
Last updated
2014-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-invasive Hb Measurement in Children

Keywords

non-invasive Hb measurement in children

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.

Interventions

DEVICEnon-invasive measurement of Hb

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Adviaone day

Secondary

MeasureTime frameDescription
influence of inhalation anestheticsone dayThe 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026