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Effectiveness of the Routine Use of Extubation Protocol on the Incidence of Occurrence of Failures Number of Extubation in Pediatric Resuscitation

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT03129815
Collaborator
(none)
70
Enrollment
1
Location
12
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is between 4 and 22% failures. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. The extubation is codified in adult resuscitation and tends to be increasingly in pediatric resuscitation. In the pediatric intensive care unit of Hautepierre, a extubation protocol already exists for some time, and was prepared to go. the current literature data. It allows the harmonization of practices in service (previously left to the discretion of each doctor).

The investigators are looking to see if the protocol used systematically in the service enables a reduction in the incidence of occurrence of failures of extubation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Jul 1, 2016
    Anticipated Primary Completion Date :
    Jul 1, 2017
    Anticipated Study Completion Date :
    Jul 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Failure of extubation [need for a new intubation within the first 48 hours after extubation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.

    • Children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes.

    Exclusion Criteria:
    • Refusal to participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Reanimation Pediatrique Specialisee - S. Continue Strasbourg F 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:
    NCT03129815
    Other Study ID Numbers:
    • 6360
    First Posted:
    Apr 26, 2017
    Last Update Posted:
    May 11, 2017
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University Hospital, Strasbourg, France
    extubation
    pediatric resuscitation
    reintubation
    failures of extubation.
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of May 11, 2017