Pedia-Card: How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05546983
Collaborator
(none)
189
1
12
15.8

Study Details

Study Description

Brief Summary

Congenital heart disease is a common abnormality in newborns. The marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. With the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    189 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?
    Actual Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Retrospective analysis of the quality criteria described in the literature after pediatric cardiac surgery by studying their behavior within a local cohort within the University Hospitals of Strasbourg [Files analysed retrospectively from January 01, 2010 to March 31, 2022 will be examined]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Inclusion criteria:
    • Minor patients, under the age of 18

    • operated at the HUS between 01/01/2010 and 03/31/2022 for transposition surgery of the great vessels (arterial switch) with or without CIV; or isolated ventricular septal closure

    • Child or holders of parental authority who do not object to the reuse of their data for scientific research purposes.

    Exclusion criteria:
    • Transposition surgery of the great vessels associated with coarctation of the aorta, pulmonary stenosis or any other complex malformation

    • Surgical technique different from the arterial switch for the transpositions of the great vessels

    • Closure of interventricular communication associated with another complex heart malformation (tetralogy of Fallot, atrioventricular canal, right ventricle with double outlet, etc.)

    • Child or holders of parental authority who have expressed their opposition to the reuse of their data for scientific research purposes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Pédiatrie 1 - CHU de Strasbourg - France Strasbourg France 67091

    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:
    NCT05546983
    Other Study ID Numbers:
    • 8717
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2022