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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

Tracking Information
First Submitted Date  ICMJE October 26, 2014
First Posted Date  ICMJE October 28, 2014
Last Update Posted Date November 13, 2014
Study Start Date  ICMJE October 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
Intubation Time [ Time Frame: 1 month ]
time in seconds required for a successful intubation attempt with the five different ETI devices
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • Successful intubation [ Time Frame: 1 month ]
    effectiveness of first, second, third intubation attempts and overall effectiveness intubation attempt using all intubation devices
  • POGO score [ Time Frame: 1 month ]
    self reported percentage og glottis opening (POGO) score
  • 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).
  • Preferred ETI device [ Time Frame: 1 month ]
    participants were asked which method of ETI they would prefer in a real-life resuscitation.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intubation During Pediatric Resuscitation
Official Title  ICMJE Pediatric Tracheal Intubation Using Four Video-laryngoscopes and the Miller Laryngoscope With and Without Chest Compressions
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Arrest
  • Endotracheal Intubation
  • Pediatric Manikin
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: ETI without chest compressions
    Endotracheal intubation during pediatric resuscitation without chest compressions.
    Interventions:
    • Device: Miller Laryngoscope
    • Device: The Berci-Kaplan DCI
    • Device: The AirTraq
    • Device: GlideScope GVL
    • Device: The Pentax AWS
  • Experimental: ETI with chest compressions
    Endotracheal intubation during pediatric resuscitation with chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control).
    Interventions:
    • Device: Miller Laryngoscope
    • Device: The Berci-Kaplan DCI
    • Device: The AirTraq
    • Device: GlideScope GVL
    • Device: The Pentax AWS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 11, 2014)
94
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2014)
150
Estimated Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02277015
Other Study ID Numbers  ICMJE ETI/2014/02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
Study Sponsor  ICMJE International Institute of Rescue Research and Education
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lukasz Szarpak Institute of Cardiology, Warsaw, Poland
PRS Account International Institute of Rescue Research and Education
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP