Intubation During Pediatric Resuscitation

• ClinicalTrials.gov Identifier: NCT02277015
• Recruitment Status: Unknown
• First Posted: October 28, 2014
• Last Update Posted: November 13, 2014
• Sponsor: International Institute of Rescue Research and Education
• Information provided by (Responsible Party): Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

Tracking Information

• First Submitted Date: October 26, 2014
• First Posted Date: October 28, 2014
• Last Update Posted Date: November 13, 2014
• Study Start Date: October 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intubation During Pediatric Resuscitation
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Cardiac Arrest
• Endotracheal Intubation
• Pediatric Manikin

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: November 11, 2014): 94
• Original Estimated Enrollment (submitted: October 27, 2014): 150
• Estimated Study Completion Date: November 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT02277015
• Other Study ID Numbers: ETI/2014/02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
• Study Sponsor: International Institute of Rescue Research and Education
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lukasz Szarpak; Institute of Cardiology, Warsaw, Poland

• PRS Account: International Institute of Rescue Research and Education
• Verification Date: October 2014