The Accuracy of Noninvasive and Continuous Hemoglobin Mea... | NCT01364116

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

NCT01364116

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jun 6, 2012Estimated

Enrollment

46Actual

Phase

Not provided

Conditions

Continuous Hemoglobin Measurement

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Not provided

Completion Date

Dec 2011Actual

First Submitted Date

May 24, 2011

First Submission Date that Met QC Criteria

May 31, 2011

First Posted Date

Jun 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2012

Last Update Posted Date

Jun 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hemoglobin concentrations from laboratory lab and pulse Co-oximetry	volume expansion will be performed for 20 minuntes	before and after volume expansion (20 minutes)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

10 Years

Standard Ages

Child

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea