Intubation During Pediatric Resuscitation

November 11, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

Pediatric Tracheal Intubation Using Four Video-laryngoscopes and the Miller Laryngoscope With and Without Chest Compressions

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovia
      • Warsaw, Masovia, Poland, 03-122
        • International Institute of Rescue Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Time
Time Frame: 1 month
time in seconds required for a successful intubation attempt with the five different ETI devices
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful intubation
Time Frame: 1 month
effectiveness of first, second, third intubation attempts and overall effectiveness intubation attempt using all intubation devices
1 month
POGO score
Time Frame: 1 month
self reported percentage og glottis opening (POGO) score
1 month
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).
1 month
Preferred ETI device
Time Frame: 1 month
participants were asked which method of ETI they would prefer in a real-life resuscitation.
1 month
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.
1 month
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.
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Institute of Rescue Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ANTICIPATED)

November 1, 2014

Study Registration Dates

First Submitted

October 26, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (ESTIMATE)

October 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 11, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETI/2014/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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