Pediatric Intubation During Emergency Conditions

Sponsor
Lazarski University (Other)
Overall Status
Completed
CT.gov ID
NCT03602183
Collaborator
Wroclaw Medical University (Other), The Cleveland Clinic (Other), Medical University of Vienna (Other)
83
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11.8
7.1

Study Details

Study Description

Brief Summary

The effectiveness of endotracheal intubation in pre-hospital conditions is insufficient - especially in the context of pediatric patients. Anatomical differences in pediatric patients compared to adults: a relative larger tongue, a larger and more flabby epiglottis - located more cephalously - that make intubation is more difficult than for adults. Also, higher oxygen metabolism requires the immediate response of medical personnel to children in case of need to protect the airways and support breath.

Condition or Disease Intervention/Treatment Phase
  • Device: Macintosh laryngoscope
  • Device: Miller laryngoscope
  • Device: McGrath MAC EMS
  • Device: GlideScope
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
83 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparison of Direct vs. Video-laryngoscopes for Different Emergency Pediatric Airway Scenarios
Actual Study Start Date :
Jul 27, 2018
Actual Primary Completion Date :
Jul 20, 2019
Actual Study Completion Date :
Jul 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Normal airway scenario

intubation in normal airway scenario

Device: Macintosh laryngoscope
intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
Other Names:
  • MAC
  • Device: Miller laryngoscope
    intubation will be performed using Miller laryngoscope
    Other Names:
  • MIL
  • Device: McGrath MAC EMS
    intubation will be performed using McGrath MAC EMS video - laryngoscope
    Other Names:
  • McGrath
  • Device: GlideScope
    intubation will be performed using GlideScope video - laryngoscope
    Other Names:
  • GLS
  • Experimental: Tongue edema scenario

    intubation in the tongue edema scenario. Tongue edema was obtain using simulator indicators

    Device: Macintosh laryngoscope
    intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
    Other Names:
  • MAC
  • Device: Miller laryngoscope
    intubation will be performed using Miller laryngoscope
    Other Names:
  • MIL
  • Device: McGrath MAC EMS
    intubation will be performed using McGrath MAC EMS video - laryngoscope
    Other Names:
  • McGrath
  • Device: GlideScope
    intubation will be performed using GlideScope video - laryngoscope
    Other Names:
  • GLS
  • Experimental: Spinal immobilization with normal airway scenario

    intubation in spinal immobilization with normal airway scenario

    Device: Macintosh laryngoscope
    intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
    Other Names:
  • MAC
  • Device: Miller laryngoscope
    intubation will be performed using Miller laryngoscope
    Other Names:
  • MIL
  • Device: McGrath MAC EMS
    intubation will be performed using McGrath MAC EMS video - laryngoscope
    Other Names:
  • McGrath
  • Device: GlideScope
    intubation will be performed using GlideScope video - laryngoscope
    Other Names:
  • GLS
  • Experimental: Spinal immobilization with tongue edema scenario

    endotracheal intubation with immobilized cervical spine and tongue edema scenario

    Device: Macintosh laryngoscope
    intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
    Other Names:
  • MAC
  • Device: Miller laryngoscope
    intubation will be performed using Miller laryngoscope
    Other Names:
  • MIL
  • Device: McGrath MAC EMS
    intubation will be performed using McGrath MAC EMS video - laryngoscope
    Other Names:
  • McGrath
  • Device: GlideScope
    intubation will be performed using GlideScope video - laryngoscope
    Other Names:
  • GLS
  • Outcome Measures

    Primary Outcome Measures

    1. Intubation time [1 day]

      time in seconds required for a successful intubation attempt

    Secondary Outcome Measures

    1. Success of intubation [1 day]

      If the oesopharyngeal tube was incorrectly placed or intubation lasted longer than 60 seconds, the airway-management attempt was defined as a failure.

    2. Cormack-Lehane grading [1 day]

      self-reported percentage the vocal cord visualization using the Cormack-Lehane grading, scale developed by Cormack and Lehane, based on four degrees of visibility of the glottis.

    3. POGO score - percentage of glottic opening [1 day]

      self-reported percentage the vocal cord visualization. A 100% POGO score is a full view of the glottis from the anterior commissure to the interarytenoid notch. A POGO score of 0 means that even the interarytenoid notch is not seen.

    4. Preferred ETI device [1 day]

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

    5. Ease of use [1 day]

      self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • paramedics

    • give voluntary consent to participate in the study

    • none experience in videolaryngoscopy

    • less than 1 year experience in medicine

    Exclusion Criteria:
    • not meet the above criteria

    • wrist or low back diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lazarsku University Warsaw Masovian Poland 02-662

    Sponsors and Collaborators

    • Lazarski University
    • Wroclaw Medical University
    • The Cleveland Clinic
    • Medical University of Vienna

    Investigators

    • Principal Investigator: Lukasz Szarpak, PhD, Lazarski University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Łukasz Szarpak, Associate Professor, Lazarski University
    ClinicalTrials.gov Identifier:
    NCT03602183
    Other Study ID Numbers:
    • ETI_2018_PALS
    First Posted:
    Jul 26, 2018
    Last Update Posted:
    Jul 31, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Łukasz Szarpak, Associate Professor, Lazarski University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 31, 2019