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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Non-invasive Hb Measurement in Children

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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inhalation group

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

Group Type OTHER

non-invasive measurement of Hb

Intervention Type DEVICE

taking blood samples

Intervention Type PROCEDURE

non-inhalational

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

Group Type OTHER

non-invasive measurement of Hb

Intervention Type DEVICE

taking blood samples

Intervention Type PROCEDURE

Interventions

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non-invasive measurement of Hb

Intervention Type DEVICE

taking blood samples

Intervention Type PROCEDURE

Other Intervention Names

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SpHb (®) by Masimo ® Radical 7 blood for BGA (ABL 800) blood for laboratory Hb (Siemens Advia)

Eligibility Criteria

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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

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No