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Pediatric Intubation During Resuscitation (PIDR)

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ClinicalTrials.gov Identifier: NCT02277405
Recruitment Status : Unknown
Verified October 2014 by Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

Study Description
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Brief Summary:
The aim of the study was to compare time and success rates of four intubation devices in a cardiopulmonary scenario with and without chest compressions with a standardized pediatric manikin model.

Condition or disease Intervention/treatment Phase
Intubation Resuscitation Device: Shikani Optical Stylet Device: Endoeye Flexible Intubation (LF-V) Not Applicable

Detailed Description:
Emergency airway management during resuscitation is a critical skill in emergency medicine. According to the European Resuscitation Council (ERC) guidelines for resuscitation 2010 , endotracheal intubation (ETI) is considered the gold standard during resuscitation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Endotracheal Intubation Using the Shikani Optical Stylet or the Endoeye Flexible Intubation During Pediatric Resuscitation
Study Start Date : October 2014
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intubation without chest compressions
Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.
 Device: Shikani Optical Stylet
Optical intubation

Device: Endoeye Flexible Intubation (LF-V)
endoscopy intubation
Experimental: Intubation with uninterrupted chest compressions
Endotracheal intubation of pediatric mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).
 Device: Shikani Optical Stylet
Optical intubation

Device: Endoeye Flexible Intubation (LF-V)
endoscopy intubation


Outcome Measures
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Primary Outcome Measures :
  1. Time to intubation [ Time Frame: 1 month ]
    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 Outcome Measures :
  1. Success of intubation [ Time Frame: 1 month ]
    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. VAS score [ Time Frame: 1 month ]
    participants were asked which method they would prefer in a real-life resuscitation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • give voluntary consent to participate in the study
  • minimum 1 year of work experience in emergency medicine
  • experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

  • not meet the above criteria
  • wrist or low back diseases
Contacts and Locations
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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): NCT02277405


Contacts
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Contact: Lukasz Czyzewski +48696457655 czyzewski_lukasz@wp.pl

Locations
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Poland
International Institute of Rescue Research and Education Recruiting
Warsaw, Masovia, Poland, 03-122
Contact: Lukasz Szarpak    (+48)500186225    lukasz.szarpak@gmail.com   
Sponsors and Collaborators
International Institute of Rescue Research and Education
Investigators
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Principal Investigator: Lukasz Szarpak Institute of Cardiology, Warsaw, Poland
More Information
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Responsible Party: Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02277405    
Other Study ID Numbers: ETI/2014/04
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014