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Pediatric Intubation Among Nursing

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Unknown status
CT.gov ID
NCT02291640
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 aim of this study was to compare time, success rates of video laryngoscope and direct laryngoscope for the emergency intubation with an immobilized cervical spine in a standardized pediatric manikin model.

Condition or Disease Intervention/Treatment Phase
  • Device: MIL
  • Device: CoPilot
 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:
Coparison of Miller and CoPilot Laryngoscopes for Intubation by Nurses During Child Chest Compression. A Manikin Study
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: Child ETI with chest compressions

endotracheal intubation (ETI) during child mannikin resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).

Device: MIL
direct laryngoscopy
Other Names:
  • Miller laryngoscope

    • Device: CoPilot
    video laryngoscopy
    Other Names:
  • CoPilot VideoLaryngoscope

    		•
    Experimental: Child ETI without chest compressions

    Endotracheal intubation of child mannikin during resuscitation without chest compressions.

    Device: MIL
    direct laryngoscopy
    Other Names:
  • Miller laryngoscope

    • Device: CoPilot
    video laryngoscopy
    Other Names:
  • CoPilot VideoLaryngoscope

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success of intubation [1 day]

      effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices.

    Secondary Outcome Measures

    1. Time to intubation [1 day]

      time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.If the examinee failed at all attempts, the case was excluded from the time calculations.

    Other Outcome Measures

    1. Cormack-Lehan scale [1 day]

      self reported Cormack-Lehan scale during intubation

    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 nursing

    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

    • Principal Investigator: Lukasz Szarpak, Institute of Cardiology

    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:
    NCT02291640
    Other Study ID Numbers:
    • ETI/2014/16
    First Posted:
    Nov 14, 2014
    Last Update Posted:
    Nov 14, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Nov 14, 2014