Effectiveness of Pediatric Intubation (PETI)

November 12, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

Comparison of the Venner(TM) A.P. Advance(TM) With the Macintosh Laryngoscope for Emergency Intubation in a Standardized Airway Manikin With and Without Chest Compressions by Nurses. A Randomized, Controlled Crossover Trial.

We hypothesized that the Venner videolaryngoscope (A.P. Advance™) is beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of the Venner videolaryngoscope (A.P. Advance™) and MIL laryngoscopes in child resuscitation with and without CC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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
        • Sub-Investigator:
          • Andrzej Kurowski, PhD, MD

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 nursing

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: Intubation without chest compressions
Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.
Device: Venner
Video-laryngoscopy
Other Names:
  • The Venner A.P. Advance Video Laryngoscope
Device: Miller
Direct-Laryngoscopy
Other Names:
  • Miller Laryngoscope
Experimental: Intubation with uninterrupted chest compressions
Endotracheal intubation of pediatric 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: Venner
Video-laryngoscopy
Other Names:
  • The Venner A.P. Advance Video Laryngoscope
Device: Miller
Direct-Laryngoscopy
Other Names:
  • Miller Laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of intubation
Time Frame: 1 MONTH
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
1 MONTH

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: 1 MONTH
time in seconds required for a successful intubation attempt
1 MONTH
Cormack-Lehane grading
Time Frame: 1 MONTH
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
1 MONTH
POGO score
Time Frame: 1 MONTH
self-reported percentage of glottis opening (POGO) score
1 MONTH

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 10, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 12, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETI/2014/12

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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