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CompletedNCT01364116Updated Jun 6, 2012

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

An observational study in Continuous Hemoglobin Measurement, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 1 Month to 10 Years. Per ClinicalTrials.gov, last updated 2012-06-06.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
46
Ages
1 Month to 10 Years
Sex
All
01

Study 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
02

Conditions studied

  • Continuous Hemoglobin Measurement

Keywords

  • Pulse CO-Oximetry™
  • children
  • noninvasive
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 10 Years
Sexes eligible
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.

Eligibility 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
46 participants (actual)
06

What researchers measure

Primary outcomes

  1. hemoglobin concentrations from laboratory lab and pulse Co-oximetry

    volume expansion will be performed for 20 minuntes

    Time frame: before and after volume expansion (20 minutes)

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01364116
Lead sponsor
Seoul National University Hospital
Responsible party
Jin-Tae Kim (assistant professor, Seoul National University Hospital) — Principal investigator
First posted
Jun 2, 2011
Start date
Feb 2011
Completion
Dec 2011
Last update
Jun 6, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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