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SLETI: Intubation During Adult Intubation

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Unknown status
CT.gov ID
NCT02305524
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
30
Duration (Days)
152.2
Patients Per Site Per Month

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 EMS-paramedics.

Condition or Disease Intervention/Treatment Phase
  • Device: ETView VivaSight SL
  • Device: Macintosh laryngoscope
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Chest Compression Effect on Airway Management With he Visualized Tracheoscopic Ventilation Tube and the Macintosh Laryngoscopy by Novice Paramedics: a Randomized Crossover Simulation Study.
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: 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: ETView VivaSight SL
Intubation using ETView VivaSight SL

Device: Macintosh laryngoscope
intubation with macintosh laryngoscope with conventional tube
Experimental: ETI without chest compressions

Endotracheal intubation of child mannikin during resuscitation without chest compressions.

Device: ETView VivaSight SL
Intubation using ETView VivaSight SL

Device: Macintosh laryngoscope
intubation with macintosh laryngoscope with conventional tube

Outcome Measures

Primary 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.

Secondary 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.

  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

  • minimum 1 year of work experience in emergency medicine

  • experienced emergency medical personnel (physicians, nurses, paramedics)

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 04-628

Sponsors and Collaborators

  • International Institute of Rescue Research and Education

Investigators

None specified.

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:
NCT02305524
Other Study ID Numbers:
  • ETI/2014/44
First Posted:
Dec 2, 2014
Last Update Posted:
Dec 2, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
endotracheal intubation
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of Dec 2, 2014