Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 195
- Primary Endpoint
- level of hemoglobin using 3 different techniques at the time of transfusion decision
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Paediatric patients scheduled for surgery under general anesthesia
- •Arterial catheter necessary in the anesthetic protocol
- •Written consent of holders of parental authority
- •No opposition of children
Exclusion Criteria
- •Hemoglobine disease
Arms & Interventions
Hemoglobin monitoring
3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement
Intervention: blood measurement (Device)
Hemoglobin monitoring
3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement
Intervention: pulse co-oxymeter (SpHb) (Device)
Hemoglobin monitoring
3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement
Intervention: hemoCue (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported