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Endotracheal Intubation in Prehospital Scenario

Sponsor
Medical University of Warsaw (Other)
Overall Status
Completed
CT.gov ID
NCT02681835
Collaborator
(none)
78
Enrollment
1
Location
3
Arms
29
Duration (Days)
81.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions.

Condition or Disease Intervention/Treatment Phase
  • Device: C-MAC laryngoscope
  • Device: Macintosh laryngoscope
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the C-MAC and Macintosh Laryngoscopes for Tracheal Intubation in Different Intubator Positions. A Randomized, Crossover, Manikin Trial
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Position 1

Standard position during intubation. Intubator is behind head of the victim, propped up on both elbows

Device: C-MAC laryngoscope
Intubation performed using C-MAC laryngoscope
Other Names:
  • C-MAC

    • Device: Macintosh laryngoscope
    Intubation performed using laryngoscope with Macintosh blade
    Other Names:
  • C-MAC

    		•
    Experimental: Position 2

    Intubator is behind head of the victim, lies on the left side

    Device: C-MAC laryngoscope
    Intubation performed using C-MAC laryngoscope
    Other Names:
  • C-MAC

    • Device: Macintosh laryngoscope
    Intubation performed using laryngoscope with Macintosh blade
    Other Names:
  • C-MAC

    		•
    Experimental: Position 3

    Intubator stands astride the victims, intubated using the face-to-face

    Device: C-MAC laryngoscope
    Intubation performed using C-MAC laryngoscope
    Other Names:
  • C-MAC

    • Device: Macintosh laryngoscope
    Intubation performed using laryngoscope with Macintosh blade
    Other Names:
  • C-MAC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time required for successful intubation [1 day]

    Secondary Outcome Measures

    1. success rate of intubation attempt [1 day]

      success rate of first, second and third intubation attempt

    2. cumulative success ratios related to time [1 day]

      cumulative success ratio was counted as percentage of successful intubations in time intervals in all scenarios

    3. Ease of intubation [1 day]

      To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).

    4. Cormack&Lehane grade [1 day]

      glottic view during intubation rate using Cormack&Lehane grade

    5. Dental Compression [1 day]

      the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009)

    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

    • maximum 1 year of work experience in medicine

    • minimum 50 clinical intubations

    • paramedics

    Exclusion Criteria:

    • not meet the above criteria

    • wrist or low back diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Warsaw, Department of Emergency Medicine Warsaw Masovia Poland 02-005

    Sponsors and Collaborators

    • Medical University of Warsaw

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Łukasz Szarpak, Principal Investigator, Medical University of Warsaw
    ClinicalTrials.gov Identifier:
    NCT02681835
    Other Study ID Numbers:
    • 02.007.1MR
    First Posted:
    Feb 12, 2016
    Last Update Posted:
    Mar 9, 2016
    Last Verified:
    Mar 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided

    Study Results

    No Results Posted as of Mar 9, 2016