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The Accuracy of Noninvasive and Continuous Hemoglobin Measurement by Pulse CO-Oximetry™ in Children Undergoing Volume Expansion

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ClinicalTrials.gov Identifier: NCT01364116
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Brief Summary:

Measuring total hemoglobin(tHb) is a precious step to decide to start or to stop transfusion during operation. The newly developed instrument pulse CO-Cooximetry (Masimo) makes noninvasive monitoring of venous hemoglobin level (SpHb).

The objective of this study

  • to compare the simultaneous level of tHb and SpHb during operation and after volume expansion in children
  • to assess the accuracy of amount of acute change of SpHb on Masimo and tHb

Condition or disease
Continuous Hemoglobin Measurement

Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : February 2011
Study Completion Date : December 2011

Primary Outcome Measures :
  1. hemoglobin concentrations from laboratory lab and pulse Co-oximetry [ Time Frame: before and after volume expansion (20 minutes) ]
    volume expansion will be performed for 20 minuntes

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children under 10 years old who were planned to take elective surgery which may cause patients' hemodynamic unstability.

Patients who require intraoperative invasive arterial blood pressure monitoring.


Inclusion Criteria: children under 10 years old how are diagnosed as

  • brain tumor
  • intraabdominal tumor
  • intrathoracic tumor
  • craniosynostosis
  • scoliosis

Exclusion Criteria:

  • cardiopulmonary disease
  • preoperative infection
  • genetic disease
  • hematologic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364116

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Jin-Tae Kim, assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01364116     History of Changes
Other Study ID Numbers: H-1012-127-346
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
Pulse CO-Oximetry™