Pediatric Difficult Intubation (3V-L DL)

November 18, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

Can the Vividtrac Laryngoscope Rival the Miller Laryngoscope for Child Tracheal Intubation During Chest Compression in a Manikin? A Randomized Crossover Trial.

Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR). These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. The aim of the study was to compare time and success rates of the Vividtrac video-laryngoscope and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

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
        • Recruiting
        • 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
  • Paramedic student

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endotracheal intubation without chest compressions
Endotracheal intubation of mannikin during resuscitation without chest compressions.
Device: MIL
direct-laryngoscopy
Other Names:
  • miller larygoscopy
Device: Vividtrac
video-laryngoscopy
Experimental: Endotracheal intubation with uninterrupted chest compressions
Endotracheal intubation of mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).
Device: MIL
direct-laryngoscopy
Other Names:
  • miller larygoscopy
Device: Vividtrac
video-laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to intubation
Time Frame: 1 day
time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cormack-Lehane grading
Time Frame: 1 day
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
1 day
Success of intubation
Time Frame: 1 day

effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.

Visual Analog scale (VAS) score
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

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 (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETI/2014/51

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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