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OpenTrials
Completed

NCT Number: NCT03602183

Pediatric Intubation During Emergency Conditions

The effectiveness of endotracheal intubation in pre-hospital conditions is insufficient - especially in the context of pediatric patients. Anatomical differences in pediatric patients compared to adults: a relative larger tongue, a larger and more flabby epiglottis - located more cephalously - that make intubation is more difficult than for adults. Also, higher oxygen metabolism requires the immediate response of medical personnel to children in case of need to protect the airways and support breath.

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Key information

Conditions

Endotracheal Intubation Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Injuries Pediatric Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lazarsku University

Warsaw, Masovian Voivodeship, 02-662, Poland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • paramedics
  • give voluntary consent to participate in the study
  • none experience in videolaryngoscopy
  • less than 1 year experience in medicine

Exclusion criteria

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

Treatment and study plan

Macintosh laryngoscope

Device

intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope

Other names: MAC

Miller Laryngoscope

Device

intubation will be performed using Miller laryngoscope

Other names: MIL

McGrath MAC EMS

Device

intubation will be performed using McGrath MAC EMS video - laryngoscope

Other names: McGrath

Glidescope

Device

intubation will be performed using GlideScope video - laryngoscope

Other names: GLS

Primary outcomes

  1. Intubation time

    Time frame: 1 day

    time in seconds required for a successful intubation attempt

Secondary outcomes

  1. Success of intubation

    Time frame: 1 day

    If the oesopharyngeal tube was incorrectly placed or intubation lasted longer than 60 seconds, the airway-management attempt was defined as a failure.

  2. Cormack-Lehane grading

    Time frame: 1 day

    self-reported percentage the vocal cord visualization using the Cormack-Lehane grading, scale developed by Cormack and Lehane, based on four degrees of visibility of the glottis.

  3. POGO score - percentage of glottic opening

    Time frame: 1 day

    self-reported percentage the vocal cord visualization. A 100% POGO score is a full view of the glottis from the anterior commissure to the interarytenoid notch. A POGO score of 0 means that even the interarytenoid notch is not seen.

  4. Preferred ETI device

    Time frame: 1 day

    participants were asked which method of ETI they would prefer in a real-life resuscitation.

  5. Ease of use

    Time frame: 1 day

    self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy

Sponsors and collaborators

Lead sponsor

Lazarski University

Other

Collaborators

  • Medical University of Vienna
  • The Cleveland Clinic
  • Wroclaw Medical University

Registry information

Official study title

A Comparison of Direct vs. Video-laryngoscopes for Different Emergency Pediatric Airway Scenarios

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Jul 31, 2019

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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