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SL: ETI During Intubation

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Completed
CT.gov ID
NCT02295618
Collaborator
(none)
107
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a novice-physicians.

Condition or Disease Intervention/Treatment Phase
  • Device: Standard tracheal tube
  • Device: ETView VivaSight SL
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Can the ETView VivaSight SL Rival the Macintosh Laryngoscopy With Conventional Tube During Adult Resuscitation by Novice Physicians: a Randomized Crossover Simulation Study.
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: ETI with chest compressions

endotracheal intubation (ETI) during child mannikin 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: Standard tracheal tube
Intubation using Macintosh laryngoscope and standard tracheal tube

Device: ETView VivaSight SL
Intubation using ETView VivaSight SL
Experimental: ETI without chest compressions

Endotracheal intubation of child mannikin during resuscitation without chest compressions.

Device: Standard tracheal tube
Intubation using Macintosh laryngoscope and standard tracheal tube

Device: ETView VivaSight SL
Intubation using ETView VivaSight SL

Outcome Measures

Primary Outcome Measures

  1. Time to intubation [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 [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. Cormack-Lehan scale [1 day]

    self reported Cormack-Lehan scale during intubation

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

  • maximum 1 year of work experience in medicine

  • maximum 10 clinical intubations

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:
NCT02295618
Other Study ID Numbers:
  • ETI/2014/41
First Posted:
Nov 20, 2014
Last Update Posted:
Dec 2, 2014
Last Verified:
Nov 1, 2014
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of Dec 2, 2014