Venner a.p. Advance Video Laryngoscope (VAVL)

November 13, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

Intubation of Child and Infant Manikins During Resuscitation. Does the Venner™ A.P. Advance™ Video Laryngoscope Improve Nurses' Performance?

The purpose of this study was to compare the Venner a.p. advance video laryngoscope to Miller laryngoscope during resuscitation with and without chest compressions.

Study Overview

Status

Completed

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 (Actual)

112

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
        • 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 (paramedics, nurses, physicians

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Child ETI withoutchest compressions
Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.
Device: VAVL
Videolaryngoscope
Other Names:
  • Venner a.p. advance video laryngoscope
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: VAVL
Videolaryngoscope
Other Names:
  • Venner a.p. advance video laryngoscope
Device: MIL
Direct laryngoscopy
Other Names:
  • Miller Laryngoscope
EXPERIMENTAL: Infant ETI with chest compressions
endotracheal intubation (ETI) during infant mannikin resuscitation with uninterrupted chest compressions.
Device: VAVL
Videolaryngoscope
Other Names:
  • Venner a.p. advance video laryngoscope
Device: MIL
Direct laryngoscopy
Other Names:
  • Miller Laryngoscope
EXPERIMENTAL: Infant ETI without chest compressions
Endotracheal intubation of infant mannikin during resuscitation without chest compressions.
Device: VAVL
Videolaryngoscope
Other Names:
  • Venner a.p. advance video laryngoscope
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
Cormack-Lehan scale
Time Frame: 1 day
self reported Cormack-Lehan scale during intubation
1 day
POGO score
Time Frame: 1 day
self-reported percentage of glottis opening (POGO) score
1 day
VAS score
Time Frame: 1 day
participants were asked which method they would prefer in a real-life resuscitation.
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

October 1, 2014

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (ESTIMATE)

October 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • ETI/2014/05

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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