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Completed

NCT Number: NCT02634099

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

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

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Key information

Conditions

Child

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chru Nancy

Vandœuvre-lès-Nancy, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood measurement

Device

Hemoglobin measurement

pulse co-oxymeter (SpHb)

Device

non invasive method of hemoglobin measurement

hemoCue

Device

non invasive method of hemoglobin measurement

Primary outcomes

  1. comparison of hemoglobin measurement 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: Hemoped

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2015
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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