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NURS_ETI: Pediatric Intubation by Nurses

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Unknown status
CT.gov ID
NCT02294916
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
30
Duration (Days)
152.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller laryngoscope during pediatric resuscitation with and without chest compressions.

Condition or Disease Intervention/Treatment Phase
  • Device: AWS
  • Device: Intubrite
  • Device: AirTraq
  • Device: MIL
 N/A

Detailed Description

Endotracheal intubation (ETI) is a life-saving procedure performed daily in emergency medicine. The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. However, ETI with uninterrupted chest compression in patients can be a very difficult skill to acquire.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Pentax-AWS Airwayscope, Intubrite, AirTraq and Miller Laryngoscope for Tracheal Intubation by Nurses During Chest Compression in a Pediatric Manikin: A Randomised 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: Child ETI withoutchest compressions

Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.

Device: AWS
Video-laryngoscopy 1
Other Names:
  • Pentax AWS

    • Device: Intubrite
    Video-laryngoscopy 2
    Other Names:
  • Intubrite Video Laryngoscope System VLS 6600

    • Device: AirTraq
    Optical-laryngoscopy
    Other Names:
  • AirTraq Optical Laryngoscope

    • Device: MIL
    Direct-laryngoscopy
    Other Names:
  • Miller Laryngoscope

    		•
    Experimental: Child ETI with chest compressions

    Endotracheal intubation of mannikin during 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: AWS
    Video-laryngoscopy 1
    Other Names:
  • Pentax AWS

    • Device: Intubrite
    Video-laryngoscopy 2
    Other Names:
  • Intubrite Video Laryngoscope System VLS 6600

    • Device: AirTraq
    Optical-laryngoscopy
    Other Names:
  • AirTraq Optical Laryngoscope

    • Device: MIL
    Direct-laryngoscopy
    Other Names:
  • Miller Laryngoscope

    		•

    Outcome Measures

    Primary 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.

    Secondary 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. If the examinee failed at all attempts, the case was excluded from the time calculations.

    2. VAS score [1 day]

      participants were asked which method they would prefer in a real-life resuscitation.

    3. Cormack-Lehan scale [1day]

      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 emergency medicine

    • experienced emergency medical personnel - nurses

    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:
    NCT02294916
    Other Study ID Numbers:
    • ETI/2014/25
    First Posted:
    Nov 19, 2014
    Last Update Posted:
    Nov 19, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Nov 19, 2014