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OpenTrials
Completed

NCT Number: NCT02655107

Non-invasive Measurement of Hemoglobin in Infants and Neonates

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).

Completed

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Key information

Conditions

Hemoglobins

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • urgent surgery
  • premature birth
  • parents refuse

Treatment and study plan

Primary outcomes

  1. Hemoglobin measurement non-invasively compared to gold standard hemoglobin

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2016
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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