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

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Non-invasive Hb Measurement in Children

Treatments: Device: non-invasive measurement of Hb; Procedure: taking blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT01693016

MASIMO 2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: Under 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

inhalation group

Other group

Description:

20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia

Treatment:

Procedure: taking blood samples

Device: non-invasive measurement of Hb

non-inhalational

Other group

Description:

40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children.

Treatment:

Procedure: taking blood samples

Device: non-invasive measurement of Hb