Non-invasive Measurement of Hemoglobin in Infants and Neonates

Completed

• Conditions: Hemoglobins

• Registration Number: NCT02655107
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM 3500 premiere).

Detailed Description

Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM 3500 premiere). Data collection whenever an arterial blood gas analysis is indicated by the experienced attending anesthetist - before and after cardiopulmonary bypass.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-12-05
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-13
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-18
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• scheduled for elective congenital heart surgery
• routine use of an arterial line
• weight >= 3000g

Exclusion Criteria

• urgent surgery
• premature birth
• parents refuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin measurement non-invasively compared to gold standard hemoglobin	intraoperative

Trial Locations

Locations (1)

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany