A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients

Not Applicable

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

• Registration Number: NCT03624140
• 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: 2018-08-07
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27
• Study Start: 2019-03
• Primary Completion: 2023-03
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 195

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
level of hemoglobin 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