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Non-invasive Measurement of Hemoglobin in Infants and Neonates

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Completed
CT.gov ID
NCT02655107
Collaborator
(none)
60
Enrollment
1
Location
18
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non-invasive Measurement of Hemoglobin in Infants and Neonates: Comparison With CO-oximetrie and Point-of-care Devices.
    Study Start Date :
    Feb 1, 2015
    Actual Primary Completion Date :
    Jul 1, 2016
    Actual Study Completion Date :
    Aug 1, 2016

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 2 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • scheduled for elective congenital heart surgery

    • routine use of an arterial line

    • weight >= 3000g

    Exclusion Criteria:

    • urgent surgery

    • premature birth

    • parents refuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsklinikum Schleswig-Holstein Kiel Schleswig-Holstein Germany 24105

    Sponsors and Collaborators

    • University Hospital Schleswig-Holstein

    Investigators

    • Principal Investigator: Jochen Renner, PD Dr., University Hospital Schleswig-Holstein

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Jochen Renner, PhD, University Hospital Schleswig-Holstein
    ClinicalTrials.gov Identifier:
    NCT02655107
    Other Study ID Numbers:
    • AZ 119/14
    First Posted:
    Jan 13, 2016
    Last Update Posted:
    Dec 20, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Dr. Jochen Renner, PhD, University Hospital Schleswig-Holstein
    blood gas monitoring
    non-invasive
    hemoglobin

    Study Results

    No Results Posted as of Dec 20, 2016