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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Eva Wittenmeier, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01693016
First received: September 19, 2012
Last updated: March 23, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Non-invasive Hb Measurement in Children
Device: non-invasive measurement of Hb
Procedure: taking blood samples

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of Non-invasive Hb-measurement (SpHb) in Children With the Masimo@ Radical 7

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • influence of inhalation anesthetics [ Time Frame: one day ] [ Designated as safety issue: No ]
    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.


Enrollment: 81
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
inhalation group
20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia
Device: non-invasive measurement of Hb
Other Name: SpHb (®) by Masimo ® Radical 7
Procedure: taking blood samples
Other Names:
  • blood for BGA (ABL 800)
  • blood for laboratory Hb (Siemens Advia)
non-inhalational
40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children.
Device: non-invasive measurement of Hb
Other Name: SpHb (®) by Masimo ® Radical 7
Procedure: taking blood samples
Other Names:
  • blood for BGA (ABL 800)
  • blood for laboratory Hb (Siemens Advia)

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.

  Eligibility

Ages Eligible for Study:   up to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693016

Locations
Germany
Dr. Eva Wittenmeier
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Eva Wittenmeier Johannes Gutenberg University Mainz
  More Information

No publications provided

Responsible Party: Dr. Eva Wittenmeier, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01693016     History of Changes
Other Study ID Numbers: MASIMO 2012
Study First Received: September 19, 2012
Last Updated: March 23, 2014
Health Authority: Regional Ethics Committee of Rhineland-Palatinate, Mainz, Germany:

Keywords provided by Johannes Gutenberg University Mainz:
non-invasive Hb measurement in children

ClinicalTrials.gov processed this record on August 28, 2014