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Prospective Evaluation of Changes in Tissue Oxygen Saturation in Brain and Kidney in Children Admitted to Intensive Care in the Postoperative Period of Cardiac Surgery

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT02884973
Collaborator
(none)
30
Enrollment
11
Duration (Months)

Study Details

Study Description

Brief Summary

It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short term.

The advances in surgical techniques in recent years has improved the prognosis of these patients in the first months of life.

The success of surgery is, among other things, conditioned by a support per complex operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic support techniques.

These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of non-invasive tissue saturation (rSO2) in cerebral and renal oxygen.

The fundamental principle of NIRS based on an estimate of the percentage proportion of cerebral oxy-hemoglobin.

A light source is emitted by NIRS and through body tissues to the brain where the light will be absorbed and refracted depending on the tissue composition in oxy-hemoglobin.

Refracted light will be analyzed by NIRS which in turn using software will help to determine a percentage of oxyhemoglobin.

Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this principle to estimate cerebral tissue oxygenation but also for other tissues such as the kidney.

More than the figure, those are changes NIRS compared to a baseline that will alert us to the conditions of tissue oxygenation and allow us to identify hypoxia times.

Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage of oxyhemoglobin and deoxyhemoglobin percentage.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Study Start Date :
    Jul 1, 2016
    Anticipated Primary Completion Date :
    Jun 1, 2017
    Anticipated Study Completion Date :
    Jun 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. oxygen saturation in brain and kidney tissue [1 hour after cardiac surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    • Children under 5 years

    • Allowed in pediatric intensive care unit

    • Having received heart surgery for management of congenital heart disease

    Exclusion criteria

    • Patients aged over 5 years

    • Violations preexisting brain to the intervention (brain malformation)

    • Patients with congenital heart disease and admitted to intensive care for reasons other than the surgical treatment of heart disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT02884973
    Other Study ID Numbers:
    • 6156
    First Posted:
    Aug 31, 2016
    Last Update Posted:
    Aug 31, 2016
    Last Verified:
    Jun 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University Hospital, Strasbourg, France
    congenital heart
    NIRS
    Additional relevant MeSH terms:
    Heart Defects, Congenital

    Study Results

    No Results Posted as of Aug 31, 2016