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

June 5, 2012 updated by: Jin-Tae Kim, Seoul National University Hospital

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before and after volume expansion (20 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (ESTIMATE)

June 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-1012-127-346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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