Back to resultsIntubation During Adult Intubation (SLETI)
Primary Purpose
Cardiac Arrest
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
ETView VivaSight SL
Macintosh laryngoscope
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring endotracheal intubation
Eligibility Criteria
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
Sites / Locations
- International Institute of Rescue Research and EducationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ETI with chest compressions
ETI without chest compressions
Arm Description
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.).
Endotracheal intubation of child mannikin during resuscitation without chest compressions.
Outcomes
Primary Outcome Measures
Success of intubation
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
Time to intubation
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.
Cormack-Lehan scale
self reported Cormack-Lehan scale during intubation
Full Information
NCT ID
NCT02305524
First Posted
November 27, 2014
Last Updated
December 1, 2014
Sponsor
International Institute of Rescue Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT02305524
Brief Title
Intubation During Adult Intubation
Acronym
SLETI
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 Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Institute of Rescue Research and Education
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
endotracheal intubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ETI with chest compressions
Arm Type
Experimental
Arm Description
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.).
Arm Title
ETI without chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation of child mannikin during resuscitation without chest compressions.
Intervention Type
Device
Intervention Name(s)
ETView VivaSight SL
Intervention Description
Intubation using ETView VivaSight SL
Intervention Type
Device
Intervention Name(s)
Macintosh laryngoscope
Intervention Description
intubation with macintosh laryngoscope with conventional tube
Primary Outcome Measure Information:
Title
Success of intubation
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Time to intubation
Description
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.
Time Frame
1 day
Title
Cormack-Lehan scale
Description
self reported Cormack-Lehan scale during intubation
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrzej Kurowski
Phone
+48500186225
Email
andrzejkurowski987@gmail.com
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
04-628
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Phone
+48500186225
Email
lukasz.szarpak@gmail.com
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
12. IPD Sharing Statement
Learn more about this trial
Intubation During Adult Intubation
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