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
  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 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) ] [ Designated as safety issue: No ]
    volume expansion will be performed for 20 minuntes


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

Ages Eligible for Study:   1 Month to 10 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364116

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

No publications provided

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
Study First Received: May 24, 2011
Last Updated: June 5, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Pulse CO-Oximetry™
children
noninvasive

ClinicalTrials.gov processed this record on April 16, 2014