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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364116
First Posted: June 2, 2011
Last Update Posted: June 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital
  Purpose

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
Continuous Hemoglobin Measurement

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Jin-Tae Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 46
Study Start Date: February 2011
Study Completion Date: December 2011
  Eligibility

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.

Criteria

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
  Contacts and Locations
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


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

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 Submitted: May 24, 2011
First Posted: June 2, 2011
Last Update Posted: June 6, 2012
Last Verified: June 2012

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