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OpenTrials
Completed

NCT Number: NCT02572232

Supraglottic Airway Devices in Pediatric Difficult Airway Situations

The purpose of the study is to compare three supraglottic airway devices (Combitube, Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway scenario in a pediatric manikin.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Supraglottic airway devices (SAD) have been designed for the "cannot intubate, cannot ventilate" scenario in prehospital as well as intrahospital settings and are utilized in medical emergency services and emergency departments all over the world, not only for anticipated and unanticipated difficult airway situations but also as an airway device used by non-anesthesiologists or in situations where only limited practice is possible. Securing an airway in a pediatric emergency situation is crucial. Unfortunately, pediatricians usually lack the required skills and regular practice to perform endotracheal intubation (ETI, which is the gold standard for securing an airway) quickly and safely. SADs would pose a safe and feasible alternative to ETI. However, no studies on this topic are available. The investigators therefore wanted to evaluate three different SADs (Combitube, Easytube, laryngeal mask airway) in simulated difficult airway situations in a pediatric manikin in comparison to ETI.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • pediatricians
  • residents
  • interns
  • written informed consent form

Exclusion criteria

  • none

Treatment and study plan

Combitube, Easytube, Laryngeal masks

Device

Supraglottic airway device

Primary outcomes

  1. Time to successful ventilation

    Time frame: 1 min

Secondary outcomes

  1. Success rate

    Time frame: 1 min

  2. Rating of the device (questionnaire)

    Time frame: 1 min

    questionnaire, ratings from 1 (best) to 5 (worst)

  3. Re-assessment of success rate after 3 months

    Time frame: 3 months

  4. Re-assessment of time to successful ventilation after 3 months

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Comparison of Three Different Supraglottic Airway Devices and Endotracheal Intubation in Pediatric Difficult Airway Situations in a Manikin

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 8, 2015
Registry last updated
Aug 16, 2018

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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