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Intubation During Pediatric Resuscitation

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Unknown status
CT.gov ID
NCT02277015
Collaborator
(none)
94
Enrollment
1
Location
2
Arms
1
Duration (Months)
92.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Miller Laryngoscope
  • Device: The Berci-Kaplan DCI
  • Device: The AirTraq
  • Device: GlideScope GVL
  • Device: The Pentax AWS
 N/A

Study Design

Study Type:
Interventional
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 :
Oct 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Anticipated Study Completion Date :
Nov 1, 2014

Arms and Interventions

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

Primary Outcome Measures

  1. Intubation Time [1 month]

    time in seconds required for a successful intubation attempt with the five different ETI devices

Secondary Outcome Measures

  1. Successful intubation [1 month]

    effectiveness of first, second, third intubation attempts and overall effectiveness intubation attempt using all intubation devices

  2. POGO score [1 month]

    self reported percentage og glottis opening (POGO) score

  3. VAS score [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 [1 month]

    participants were asked which method of ETI they would prefer in a real-life resuscitation.

  5. First Pass Attempt [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 [intraoperative]

    Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 International Institute of Rescue Research and Education Warsaw Masovia Poland 03-122

Sponsors and Collaborators

  • International Institute of Rescue Research and Education

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT02277015
Other Study ID Numbers:
  • ETI/2014/02
First Posted:
Oct 28, 2014
Last Update Posted:
Nov 13, 2014
Last Verified:
Oct 1, 2014
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of Nov 13, 2014