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Venner a.p. Advance Video Laryngoscope (VAVL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277418
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intubation Resuscitation Device: VAVL Device: MIL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intubation of Child and Infant Manikins During Resuscitation. Does the Venner™ A.P. Advance™ Video Laryngoscope Improve Nurses' Performance?
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Child ETI withoutchest compressions
Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.
Device: VAVL
Videolaryngoscope
Other Name: Venner a.p. advance video laryngoscope

Device: MIL
Direct laryngoscopy
Other Name: 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 Name: Venner a.p. advance video laryngoscope

Device: MIL
Direct laryngoscopy
Other Name: Miller Laryngoscope

Experimental: Infant ETI with chest compressions
endotracheal intubation (ETI) during infant mannikin resuscitation with uninterrupted chest compressions.
Device: VAVL
Videolaryngoscope
Other Name: Venner a.p. advance video laryngoscope

Device: MIL
Direct laryngoscopy
Other Name: Miller Laryngoscope

Experimental: Infant ETI without chest compressions
Endotracheal intubation of infant mannikin during resuscitation without chest compressions.
Device: VAVL
Videolaryngoscope
Other Name: Venner a.p. advance video laryngoscope

Device: MIL
Direct laryngoscopy
Other Name: Miller Laryngoscope




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. POGO score [ Time Frame: 1 day ]
    self-reported percentage of glottis opening (POGO) score

  3. VAS score [ Time Frame: 1 day ]
    participants were asked which method they would prefer in a real-life resuscitation.

  4. Cormack-Lehan scale [ Time Frame: 1 day ]
    self reported Cormack-Lehan scale during intubation



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277418


Locations
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Poland
International Institute of Rescue Research and Education
Warsaw, Masovia, Poland, 03-122
Sponsors and Collaborators
International Institute of Rescue Research and Education
Investigators
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Principal Investigator: Lukasz Szarpak Institute of Cardiology, Warsaw, Poland
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Responsible Party: Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02277418    
Other Study ID Numbers: ETI/2014/05
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014