Pediatric Intubation by Nurses (NURS_ETI)

November 16, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

Comparison of Pentax-AWS Airwayscope, Intubrite, AirTraq and Miller Laryngoscope for Tracheal Intubation by Nurses During Chest Compression in a Pediatric Manikin: A Randomised Crossover Trial.

The purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller laryngoscope during pediatric resuscitation with and without chest compressions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Endotracheal intubation (ETI) is a life-saving procedure performed daily in emergency medicine. The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. However, ETI with uninterrupted chest compression in patients can be a very difficult skill to acquire.

Study Type

Interventional

Enrollment (Anticipated)

150

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
        • 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
  • minimum 1 year of work experience in emergency medicine
  • experienced emergency medical personnel - nurses

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: Child ETI withoutchest compressions
Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.
Device: AirTraq
Optical-laryngoscopy
Other Names:
  • AirTraq Optical Laryngoscope
Device: AWS
Video-laryngoscopy 1
Other Names:
  • Pentax AWS
Device: Intubrite
Video-laryngoscopy 2
Other Names:
  • Intubrite Video Laryngoscope System VLS 6600
Device: MIL
Direct-laryngoscopy
Other Names:
  • Miller Laryngoscope
Experimental: Child ETI with 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: AirTraq
Optical-laryngoscopy
Other Names:
  • AirTraq Optical Laryngoscope
Device: AWS
Video-laryngoscopy 1
Other Names:
  • Pentax AWS
Device: Intubrite
Video-laryngoscopy 2
Other Names:
  • Intubrite Video Laryngoscope System VLS 6600
Device: MIL
Direct-laryngoscopy
Other Names:
  • Miller Laryngoscope

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
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.
1 day
VAS score
Time Frame: 1 day
participants were asked which method they would prefer in a real-life resuscitation.
1 day
Cormack-Lehan scale
Time Frame: 1day
self reported Cormack-Lehan scale during intubation
1day

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 16, 2014

First Submitted That Met QC Criteria

November 16, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 16, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETI/2014/25

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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