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Supraglottic Airway Devices in Pediatric Difficult Airway Situations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572232
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Frass, Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Airway Morbidity Emergencies Device: Combitube, Easytube, Laryngeal masks Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Three Different Supraglottic Airway Devices and Endotracheal Intubation in Pediatric Difficult Airway Situations in a Manikin
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Combitube, Easytube, Laryngeal masks
Combitube, Easytube, Laryngeal mask airway are intubated in pediatric airway manikins by probands in randomized order.
Device: Combitube, Easytube, Laryngeal masks
Supraglottic airway device




Primary Outcome Measures :
  1. Time to successful ventilation [ Time Frame: 1 min ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pediatricians
  • residents
  • interns
  • written informed consent form

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572232


Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Chair: Michael Frass, Prof. Dr. Medical University of Vienna
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Responsible Party: Michael Frass, Univ.Prof.Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02572232    
Other Study ID Numbers: 1805/2015
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes