Clincosm LogoSign in Get a demo

PETI: Effectiveness of Pediatric Intubation

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Unknown status
CT.gov ID
NCT02289651
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
30
Duration (Days)
81.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Venner
  • Device: Miller
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success of intubation [1 MONTH]

      effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants

    Secondary Outcome Measures

    1. Intubation time [1 MONTH]

      time in seconds required for a successful intubation attempt

    2. POGO score [1 MONTH]

      self-reported percentage of glottis opening (POGO) score

    3. Cormack-Lehane grading [1 MONTH]

      self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 International Institute of Rescue Research and Education Warsaw Masovia Poland 03-122

    Sponsors and Collaborators

    • International Institute of Rescue Research and Education

    Investigators

    • Principal Investigator: Lukasz Szarpak, Institute of Cardiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
    ClinicalTrials.gov Identifier:
    NCT02289651
    Other Study ID Numbers:
    • ETI/2014/12
    First Posted:
    Nov 13, 2014
    Last Update Posted:
    Nov 13, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
    intubation
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Nov 13, 2014