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Intubation During Pediatric Resuscitation

Primary Purpose

Cardiac Arrest, Endotracheal Intubation, Pediatric Manikin

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Miller Laryngoscope
The Berci-Kaplan DCI
The AirTraq
GlideScope GVL
The Pentax AWS
Sponsored by
International Institute of Rescue Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • International Institute of Rescue Research and Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ETI without chest compressions

ETI with chest compressions

Arm Description

Endotracheal intubation during pediatric resuscitation without chest compressions.

Endotracheal intubation during pediatric resuscitation with chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Successful intubation
effectiveness of first, second, third intubation attempts and overall effectiveness intubation attempt using all intubation devices
POGO score
self reported percentage og glottis opening (POGO) score
VAS score
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
participants were asked which method of ETI they would prefer in a real-life resuscitation.
First Pass Attempt
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
Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.

Full Information

First Posted
October 26, 2014
Last Updated
November 11, 2014
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02277015
Brief Title
Intubation During Pediatric Resuscitation
Official Title
Pediatric Tracheal Intubation Using Four Video-laryngoscopes and the Miller Laryngoscope With and Without Chest Compressions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Institute of Rescue Research and Education

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Endotracheal Intubation, Pediatric Manikin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ETI without chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation during pediatric resuscitation without chest compressions.
Arm Title
ETI with chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation during pediatric resuscitation with chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control).
Intervention Type
Device
Intervention Name(s)
Miller Laryngoscope
Intervention Description
Direct Laryngoscopy
Intervention Type
Device
Intervention Name(s)
The Berci-Kaplan DCI
Intervention Description
Videolaryngoscope-1
Intervention Type
Device
Intervention Name(s)
The AirTraq
Intervention Description
Videolaryngoscope-2
Intervention Type
Device
Intervention Name(s)
GlideScope GVL
Intervention Description
Videolaryngoscope-3
Intervention Type
Device
Intervention Name(s)
The Pentax AWS
Intervention Description
Videolaryngoscope-4
Primary Outcome Measure Information:
Title
Intubation Time
Description
time in seconds required for a successful intubation attempt with the five different ETI devices
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Successful intubation
Description
effectiveness of first, second, third intubation attempts and overall effectiveness intubation attempt using all intubation devices
Time Frame
1 month
Title
POGO score
Description
self reported percentage og glottis opening (POGO) score
Time Frame
1 month
Title
VAS score
Description
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).
Time Frame
1 month
Title
Preferred ETI device
Description
participants were asked which method of ETI they would prefer in a real-life resuscitation.
Time Frame
1 month
Title
First Pass Attempt
Description
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.
Time Frame
1 month
Title
Overall Success
Description
Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
03-122
Country
Poland

12. IPD Sharing Statement

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Intubation During Pediatric Resuscitation

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