Comparison Four Intubation Devices

January 31, 2015 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

Comparison of Tracheal Intubation Using the Miller, Macintosh, Phillips and Wis-Hipple Blades During Infant Resuscitation: A Randomized Crossover Simulation Trial

Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

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, 03-122
        • International Institute of Rescue Research and Education

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
  • paramedics
  • no clinical experience in infant intubation

Exclusion Criteria:

  • not meet the above criteria
  • wrist or low back diseases
  • pregnancy.

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: Intubation without chest compression
Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions.
Device: MIL
Direct laryngoscopy 1
Other Names:
  • Miller blade
Device: MAC
Direct laryngoscopy 2
Other Names:
  • Macintosh blade
Device: WIS
Direct laryngoscopy 3
Other Names:
  • Wis-Hipple blade
Device: PHIL
Direct laryngoscopy 4
Other Names:
  • Phillips blade
Experimental: Intubation with chest compression
Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year.
Device: MIL
Direct laryngoscopy 1
Other Names:
  • Miller blade
Device: MAC
Direct laryngoscopy 2
Other Names:
  • Macintosh blade
Device: WIS
Direct laryngoscopy 3
Other Names:
  • Wis-Hipple blade
Device: PHIL
Direct laryngoscopy 4
Other Names:
  • Phillips blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to intubation
Time Frame: 1 day
time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cormack-Lehane grading
Time Frame: 1 day
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
1 day
Success of intubation
Time Frame: 1 day
effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.
1 day
Ease of Use
Time Frame: 1 day
To access subjective opinions about the difficulty of the each intubation method, participants were asked to give a rating on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
1 day
POGO score
Time Frame: 1 day
The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures.
1 day
dental compression
Time Frame: 1 day
pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3)
1 day

Collaborators and Investigators

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

Sponsor

International Institute of Rescue Research and Education

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

November 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

January 31, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • ETI/2014/06

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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