A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients

Child Clinical Trial

— HEMOPED2  

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: Not yet recruiting

Administrative data

• NCT number: NCT03624140
• Other study ID #: 2018-A01379-46
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2019
• Est. completion date: May 2023

Study information

• Verified date: February 2019
• Source: Central Hospital, Nancy, France
• Contact: Claude MEISTELMAN, PhD
• Phone: 00 33 3 83 15 41 66
• Email: c.meistelman[@]chru-nancy.fr
• 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: Not yet recruiting
• Enrollment: 195
• Est. completion date: May 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Paediatric patients scheduled for surgery under general anesthesia

• Arterial catheter necessary in the anesthetic protocol

• BMI<30

• Written consent of holders of parental authority

• No opposition of children

Exclusion Criteria:

• Hemoglobine disease

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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of hemoglobin 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