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CompletedNCT02681835Updated Mar 9, 2016

Endotracheal Intubation in Prehospital Scenario

An interventional study of C-MAC laryngoscope and Macintosh laryngoscope in Endotracheal Intubation, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-09.

Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Endotracheal Intubation
03

In context

Lead sponsor

Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • not meet the above criteria
  • wrist or low back diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Position 1

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

    Device: C-MAC laryngoscope · Device: Macintosh laryngoscope

  • Experimental
    Position 2

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

    Device: C-MAC laryngoscope · Device: Macintosh laryngoscope

  • Experimental
    Position 3

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

    Device: C-MAC laryngoscope · Device: Macintosh laryngoscope

Interventions

  • DeviceC-MAC laryngoscope

    Intubation performed using C-MAC laryngoscope

    Also known as: C-MAC

  • DeviceMacintosh laryngoscope

    Intubation performed using laryngoscope with Macintosh blade

    Also known as: C-MAC

06

What researchers measure

Primary outcomes

  1. Time required for successful intubation

    Time frame: 1 day

Secondary outcomes

  1. success rate of intubation attempt

    success rate of first, second and third intubation attempt

    Time frame: 1 day

  2. cumulative success ratios related to time

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

    Time frame: 1 day

  3. Ease of intubation

    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).

    Time frame: 1 day

  4. Cormack&Lehane grade

    glottic view during intubation rate using Cormack\&Lehane grade

    Time frame: 1 day

  5. Dental Compression

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

    Time frame: 1 day

07

Study locations

1 site
  • Medical University of Warsaw, Department of Emergency Medicine
    Warsaw, Masovia 02-005, Poland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02681835
Lead sponsor
Medical University of Warsaw
Responsible party
Łukasz Szarpak (Principal Investigator, Medical University of Warsaw) — Principal investigator
First posted
Feb 12, 2016
Start date
Feb 2016
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Mar 9, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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