Non-invasive Measurement of Hemoglobin in Infants and Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Hemoglobins

Keywords

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blood gas monitoring non-invasive hemoglobin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* urgent surgery
* premature birth
* parents refuse

Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dr. Jochen Renner

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jochen Renner, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

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Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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AZ 119/14

Identifier Type: -

Identifier Source: org_study_id