Endotracheal Intubation in Prehospital Scenario

March 8, 2016 updated by: Łukasz Szarpak, Medical University of Warsaw

Comparison of the C-MAC and Macintosh Laryngoscopes for Tracheal Intubation in Different Intubator Positions. A Randomized, Crossover, Manikin Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time required for successful intubation
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate of intubation attempt
Time Frame: 1 day
success rate of first, second and third intubation attempt
1 day
cumulative success ratios related to time
Time Frame: 1 day
cumulative success ratio was counted as percentage of successful intubations in time intervals in all scenarios
1 day
Ease of intubation
Time Frame: 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).
1 day
Cormack&Lehane grade
Time Frame: 1 day
glottic view during intubation rate using Cormack&Lehane grade
1 day
Dental Compression
Time Frame: 1 day
the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 02.007.1MR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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