A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients (HEMOPED2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03624140
Recruitment Status : Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : August 10, 2018
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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

Condition or disease Intervention/treatment Phase
Child Device: blood measurement Device: pulse co-oxymeter (SpHb) Device: hemoCue Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Blood measurement
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Hemoglobin monitoring
3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement
Device: blood measurement
Hemoglobin measurement

Device: pulse co-oxymeter (SpHb)
non invasive method of hemoglobin measurement

Device: hemoCue
non invasive method of hemoglobin measurement

Primary Outcome Measures :
  1. level of hemoglobin using 3 different techniques at the time of transfusion decision [ Time Frame: within the day of surgery ]
    comparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Central Hospital, Nancy, France Identifier: NCT03624140     History of Changes
Other Study ID Numbers: 2018-A01379-46
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
major pediatric surgery
hemoglobin measurement