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Videolaryngoscopy During Child Intubation

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Unknown status
CT.gov ID
NCT02289664
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
30
Duration (Days)
81.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of three video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with and without chest compressions using an child manikin.

Condition or Disease Intervention/Treatment Phase
  • Device: MAC
  • Device: Coopdech
  • Device: CoPilot
  • Device: Intubrite
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparison of Coopdech, Intubrite, and CoPilot Video-laryngoscopes With Macintosh Laryngoscope for Tracheal Intubation in Pediatric Patients During Resuscitation. Randomized Crossover Manikin 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: Intubation without chest compressions

Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.

Device: MAC
Direct-Laryngoscopy
Other Names:
  • Macintosh Laryngoscope

    • Device: Coopdech
    Video-Laryngoscopy -1
    Other Names:
  • Coopdech Video Lartyngoscope Portable VLP-100

    • Device: CoPilot
    Video-Laryngoscopy -2
    Other Names:
  • CoPilot Video Laryngoscope

    • Device: Intubrite
    Video-Laryngoscopy -3
    Other Names:
  • Intubrite Video Laryngoscope System VLS 6600

    		•
    Experimental: Intubation with uninterrupted chest compressions

    Endotracheal intubation of pediatric 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: MAC
    Direct-Laryngoscopy
    Other Names:
  • Macintosh Laryngoscope

    • Device: Coopdech
    Video-Laryngoscopy -1
    Other Names:
  • Coopdech Video Lartyngoscope Portable VLP-100

    • Device: CoPilot
    Video-Laryngoscopy -2
    Other Names:
  • CoPilot Video Laryngoscope

    • Device: Intubrite
    Video-Laryngoscopy -3
    Other Names:
  • Intubrite Video Laryngoscope System VLS 6600

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success of intubation [1 MONTH]

      effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants using each device

    Secondary Outcome Measures

    1. Intubation time [1 MONTH]

      time in seconds required for a successful intubation attempt

    2. POGO score [1 mONTH]

      self-reported percentage of glottis opening (POGO) score

    3. Cormack-Lehane grading [1 MONTH]

      self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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 health care

    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:
    NCT02289664
    Other Study ID Numbers:
    • ETI/2014/11
    First Posted:
    Nov 13, 2014
    Last Update Posted:
    Nov 13, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
    intubation
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Nov 13, 2014