Non-invasive Measurement of Hemoglobin in Infants and Neonates

Hemoglobins Clinical Trial

Official title:

Non-invasive Measurement of Hemoglobin in Infants and Neonates: Comparison With CO-oximetrie and Point-of-care Devices.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655107
• Other study ID #: AZ 119/14
• Status: Completed
• Phase: N/A
• First received: December 5, 2015
• Last updated: December 18, 2016
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 2 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemoglobins

Locations

Country	Name	City	State
Germany	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin measurement non-invasively compared to gold standard hemoglobin		intraoperative	Yes