A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients Undergoing Major Surgery

Child Clinical Trial

— Hemoped  

Official title:

Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634099
• Other study ID #: 2015-A00916-43
• Status: Completed
• Phase: N/A
• Start date: January 5, 2016
• Est. completion date: November 23, 2016

Study information

• Verified date: August 2018
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels

Description:

The goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. During general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and SpHb

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 23, 2016
• Est. primary completion date: November 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

Inclusion Criteria:

Paediatric patients scheduled for major orthopaedi or neurosurgical process under general anesthesia Arterial catheter necessary in the anesthetic protocol. BMI<30 No opposition holders of parental authority and children.

Exclusion Criteria:

Hemoglobin disease Pretreatment with erytropoietin or iron

Related Conditions & MeSH terms

• Child

Intervention

Device:
• blood measurement
Hemoglobin measurement
• pulse co-oxymeter (SpHb)
non invasive method of hemoglobin measurement
• hemoCue
non invasive method of hemoglobin measurement

Locations

Country	Name	City	State
France	Chru Nancy	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of hemoglobin measurement using 3 different techniques at the time of transfusion decision	comparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb	within the day of surgery