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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02634099
Acronym
Hemoped
Enrollment
50
Registered
2015-12-17
Start date
2016-01-05
Completion date
2016-11-23
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child

Keywords

major pediatric surgery, hemoglobin measurement

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

Interventions

Hemoglobin measurement

non invasive method of hemoglobin measurement

DEVICEhemoCue

non invasive method of hemoglobin measurement

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
comparison of hemoglobin measurement using 3 different techniques at the time of transfusion decisionwithin the day of surgerycomparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026