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Intubation During Pediatric Resuscitation

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ClinicalTrials.gov Identifier: NCT02277015
Recruitment Status : Unknown
Verified October 2014 by Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland.
Recruitment status was:  Enrolling by invitation
First Posted : October 28, 2014
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

Study Description
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Brief Summary:
The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for endotracheal intubation (ETI) during pediatric resuscitation with and without chest compressions.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Endotracheal Intubation Pediatric Manikin Device: Miller Laryngoscope Device: The Berci-Kaplan DCI Device: The AirTraq Device: GlideScope GVL Device: The Pentax AWS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatric Tracheal Intubation Using Four Video-laryngoscopes and the Miller Laryngoscope With and Without Chest Compressions
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: ETI without chest compressions
Endotracheal intubation during pediatric resuscitation without chest compressions.
 Device: Miller Laryngoscope
Direct Laryngoscopy

Device: The Berci-Kaplan DCI
Videolaryngoscope-1

Device: The AirTraq
Videolaryngoscope-2

Device: GlideScope GVL
Videolaryngoscope-3

Device: The Pentax AWS
Videolaryngoscope-4
Experimental: ETI with chest compressions
Endotracheal intubation during pediatric resuscitation with chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control).
 Device: Miller Laryngoscope
Direct Laryngoscopy

Device: The Berci-Kaplan DCI
Videolaryngoscope-1

Device: The AirTraq
Videolaryngoscope-2

Device: GlideScope GVL
Videolaryngoscope-3

Device: The Pentax AWS
Videolaryngoscope-4


Outcome Measures
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Primary Outcome Measures :
  1. Intubation Time [ Time Frame: 1 month ]
    time in seconds required for a successful intubation attempt with the five different ETI devices


Secondary Outcome Measures :
  1. Successful intubation [ Time Frame: 1 month ]
    effectiveness of first, second, third intubation attempts and overall effectiveness intubation attempt using all intubation devices

  2. POGO score [ Time Frame: 1 month ]
    self reported percentage og glottis opening (POGO) score

  3. VAS score [ Time Frame: 1 month ]
    To assess subjective opinion about the difficulty of the procedure, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (very easy) to 5 (very difficult).

  4. Preferred ETI device [ Time Frame: 1 month ]
    participants were asked which method of ETI they would prefer in a real-life resuscitation.

  5. First Pass Attempt [ Time Frame: 1 month ]
    Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube.

  6. Overall Success [ Time Frame: intraoperative ]
    Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.


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 medicine personnel (physicians, nurses, paramedics)

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): NCT02277015


Locations
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Poland
International Institute of Rescue Research and Education
Warsaw, Masovia, Poland, 03-122
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: NCT02277015    
Other Study ID Numbers: ETI/2014/02
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases