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Pediatric Intubation (ETICPR)

Primary Purpose

Intubation, Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Macintosh Laryngoscope
TruView PCD Video laryngoscope
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 Intubation

Eligibility Criteria

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

Inclusion Criteria:

  • give voluntary consent to participate in the study
  • inexperienced in pediatric intubation paramedics

Exclusion Criteria:

  • not meet the above criteria
  • participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience

Sites / Locations

  • International Institute of Rescue Research and Education

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Scenario A

Scenario B

Scenario C

Arm Description

The control scenario, where neither chest compression nor cervical stabilization was applied during intubation.

The chest compression scenario, where continuous chest compression was applied using chest compression system LUCAS-2 (Physio-Control, Redmond, WA, USA). Chest compression was provided at a rate of 100 min-1 to a depth of 5-6 cm during all intubation procedures.

The chest compression with cervical stabilization scenario, where both chest compression using Lucas-2 and cervical stabilization were applied. A correctly fitting standard cervical immobilization collar (StifNeck Select, Laerdal, Stavanger, Norway) was applied to the manikin's neck to prevent movement of the cervical spine.

Outcomes

Primary Outcome Measures

Time to intubation
the time to intubation, defined as the time from insertion of the laryngoscope blade between the teeth to the first manual ventilation of the mannequin's lungs

Secondary Outcome Measures

Success of intubation
success of the intubation attempt (i.e. tracheal or oesophageal placement of the tube) with was recorded when the success of the ventilation attempt was seen by the manikin's ventilation indicators.
Cormack-Lehan scale
self reported Cormack-Lehan scale during intubation
Dental compression
dental compression, with was assessed using a visual scale grading the pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3).
Ease of intubation (VAS)
To access subjective opinion about the difficulty of the each intubation method, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).

Full Information

First Posted
November 7, 2014
Last Updated
January 21, 2015
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02289872
Brief Title
Pediatric Intubation
Acronym
ETICPR
Official Title
Comparison of the TruView PCD Video Laryngoscope and Macintosh Laryngoscope for Pediatric Tracheal Intubation by Novice Paramedics: A Randomized Crossover Simulation Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

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 aim of the study was to compare time and success rates of TruView PCD video laryngoscope and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios in a standardized manikin model.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scenario A
Arm Type
Experimental
Arm Description
The control scenario, where neither chest compression nor cervical stabilization was applied during intubation.
Arm Title
Scenario B
Arm Type
Experimental
Arm Description
The chest compression scenario, where continuous chest compression was applied using chest compression system LUCAS-2 (Physio-Control, Redmond, WA, USA). Chest compression was provided at a rate of 100 min-1 to a depth of 5-6 cm during all intubation procedures.
Arm Title
Scenario C
Arm Type
Experimental
Arm Description
The chest compression with cervical stabilization scenario, where both chest compression using Lucas-2 and cervical stabilization were applied. A correctly fitting standard cervical immobilization collar (StifNeck Select, Laerdal, Stavanger, Norway) was applied to the manikin's neck to prevent movement of the cervical spine.
Intervention Type
Device
Intervention Name(s)
Macintosh Laryngoscope
Intervention Description
Direct-Laryngoscopy
Intervention Type
Device
Intervention Name(s)
TruView PCD Video laryngoscope
Intervention Description
Video-Laryngoscopy
Primary Outcome Measure Information:
Title
Time to intubation
Description
the time to intubation, defined as the time from insertion of the laryngoscope blade between the teeth to the first manual ventilation of the mannequin's lungs
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Success of intubation
Description
success of the intubation attempt (i.e. tracheal or oesophageal placement of the tube) with was recorded when the success of the ventilation attempt was seen by the manikin's ventilation indicators.
Time Frame
1 day
Title
Cormack-Lehan scale
Description
self reported Cormack-Lehan scale during intubation
Time Frame
1 day
Title
Dental compression
Description
dental compression, with was assessed using a visual scale grading the pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3).
Time Frame
1day
Title
Ease of intubation (VAS)
Description
To access subjective opinion about the difficulty of the each intubation method, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
Time Frame
1 day

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 inexperienced in pediatric intubation paramedics Exclusion Criteria: not meet the above criteria participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovie
ZIP/Postal Code
03-122
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25894914
Citation
Szarpak L, Czyzewski L, Kurowski A, Truszewski Z. Comparison of the TruView PCD video laryngoscope and macintosh laryngoscope for pediatric tracheal intubation by novice paramedics: a randomized crossover simulation trial. Eur J Pediatr. 2015 Oct;174(10):1325-32. doi: 10.1007/s00431-015-2538-0. Epub 2015 Apr 18.
Results Reference
derived

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Pediatric Intubation

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