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

Not Applicable

Completed

• Conditions: Child
• Interventions: Device: blood measurement; Device: pulse co-oxymeter (SpHb); Device: hemoCue

• Registration Number: NCT02634099
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-17
• Study Start: 2016-01-05
• Primary Completion: 2016-11-23
• Study Completion: 2016-11-23
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hemoglobine monitoring	blood measurement	3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement
hemoglobine monitoring	hemoCue	3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement
hemoglobine monitoring	pulse co-oxymeter (SpHb)	3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement

Primary Outcome Measures

Name	Time	Method
comparison of hemoglobin measurement using 3 different techniques at the time of transfusion decision	within the day of surgery	comparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb

Trial Locations

Locations (1)

Chru Nancy; 🇫🇷 Vandoeuvre Les Nancy, France