- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02634099
A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients Undergoing Major Surgery (Hemoped)
August 6, 2018 updated by: Central Hospital, Nancy, France
Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin
Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vandoeuvre Les Nancy, France
- CHRU Nancy
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: hemoglobine monitoring
3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement
|
Hemoglobin measurement
non invasive method of hemoglobin measurement
non invasive method of hemoglobin measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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within the day of surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Claude MEISTELMAN, MD, CHRU Nancy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2016
Primary Completion (Actual)
November 23, 2016
Study Completion (Actual)
November 23, 2016
Study Registration Dates
First Submitted
December 8, 2015
First Submitted That Met QC Criteria
December 15, 2015
First Posted (Estimate)
December 17, 2015
Study Record Updates
Last Update Posted (Actual)
August 7, 2018
Last Update Submitted That Met QC Criteria
August 6, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2015-A00916-43
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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