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IOCPR: Intraosseous Access During Pediatric Resuscitation

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Unknown status
CT.gov ID
NCT02305511
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
30
Duration (Days)
131.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to compare the Jamshidi, the BIG, the Cook, the EZIO intraosseous devices to standard peripheral venous catheterization during pediatric resuscitation.

Condition or Disease Intervention/Treatment Phase
  • Device: Peripheral venous catheterization
  • Device: Jamshidi
  • Device: BIG
  • Device: Cook
  • Device: EZIO
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparison of Four Intraosseous Access Devices With Standard Venous Catheterization During Child Cardiopulmonary Resuscitation Simulation: a Randomized Crossover Trial.
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peripheral venous catheterization

Peripheral venous catheterization during pediatric resuscitation

Device: Peripheral venous catheterization
Cannulation using standard method
Experimental: intraosseous access

Intraosseus access using intraosseous access devices during resuscitation

Device: Jamshidi
intraosseous access using the Jamshidi device

Device: BIG
intraosseous access using the BIG device
Other Names:
  • Bone Injection Gun

    • Device: Cook
    intraosseous access using the Cook device

    Device: EZIO
    intraosseous access using the EZIO device

    Outcome Measures

    Primary Outcome Measures

    1. Success rate on first attempt [1 day]

    Secondary Outcome Measures

    1. Ease of use [1 day]

      Ease of use as reported by participants

    2. Time to successfully perform [1 day]

      Time to successfully perform the intraosseous access

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • give voluntary consent to participate in the study

    • minimum 1 year of work experience in emergency medicine

    • experienced emergency medical personnel - EMS-paramedics

    Exclusion Criteria:

    • not meet the above criteria

    • wrist or low back diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 International Institute of Rescue Research and Education Warsaw Masovia Poland 03-122

    Sponsors and Collaborators

    • International Institute of Rescue Research and Education

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
    ClinicalTrials.gov Identifier:
    NCT02305511
    Other Study ID Numbers:
    • IO/2014/01
    First Posted:
    Dec 2, 2014
    Last Update Posted:
    Dec 2, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
    Catheterization
    Peripheral
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Dec 2, 2014