Pediatric Intubation (ETICPR)

January 21, 2015 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

Comparison of the TruView PCD Video Laryngoscope and Macintosh Laryngoscope for Pediatric Tracheal Intubation by Novice Paramedics: A Randomized Crossover Simulation Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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
    • Masovie
      • Warsaw, Masovie, 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
  • 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

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scenario A
The control scenario, where neither chest compression nor cervical stabilization was applied during intubation.
Device: Macintosh Laryngoscope
Direct-Laryngoscopy
Device: TruView PCD Video laryngoscope
Video-Laryngoscopy
Experimental: Scenario B
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.
Device: Macintosh Laryngoscope
Direct-Laryngoscopy
Device: TruView PCD Video laryngoscope
Video-Laryngoscopy
Experimental: Scenario C
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.
Device: Macintosh Laryngoscope
Direct-Laryngoscopy
Device: TruView PCD Video laryngoscope
Video-Laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to intubation
Time Frame: 1 day
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cormack-Lehan scale
Time Frame: 1 day
self reported Cormack-Lehan scale during intubation
1 day
Success of intubation
Time Frame: 1 day
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.
1 day
Dental compression
Time Frame: 1day
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).
1day
Ease of intubation (VAS)
Time Frame: 1 day
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).
1 day

Collaborators and Investigators

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

Sponsor

International Institute of Rescue Research and Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TruView/01

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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