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Completed

NCT Number: NCT02280213

Comparison Four Intubation Devices

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

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Key information

Conditions

Intubation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Institute of Rescue Research and Education

Warsaw, Masovia, 03-122, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MIL

Device

Direct laryngoscopy 1

Other names: Miller blade

MAC

Device

Direct laryngoscopy 2

Other names: Macintosh blade

WIS

Device

Direct laryngoscopy 3

Other names: Wis-Hipple blade

PHIL

Device

Direct laryngoscopy 4

Other names: Phillips blade

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. Cormack-Lehane grading

    Time frame: 1 day

    self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

  5. dental compression

    Time frame: 1 day

    pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3)

Sponsors and collaborators

Lead sponsor

International Institute of Rescue Research and Education

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2014
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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