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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01364116
First received: May 24, 2011
Last updated: June 5, 2012
Last verified: June 2012

May 24, 2011
June 5, 2012
February 2011
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hemoglobin concentrations from laboratory lab and pulse Co-oximetry [ Time Frame: before and after volume expansion (20 minutes) ] [ Designated as safety issue: No ]
volume expansion will be performed for 20 minuntes
Same as current
Complete list of historical versions of study NCT01364116 on ClinicalTrials.gov Archive Site
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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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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
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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.

Continuous Hemoglobin Measurement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
December 2011
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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
Both
1 Month to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01364116
H-1012-127-346
No
Jin-Tae Kim, Seoul National University Hospital
Seoul National University Hospital
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Seoul National University Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP